(86 days)
No
The document describes a mechanical and pneumatic system for controlling pressure and oxygen concentration, with no mention of AI or ML capabilities.
Yes.
The document clearly states that the intended use of the hyperbaric chambers is to administer 100% oxygen at increased pressure for specific medical indications, which are listed as treatments for various medical conditions.
No
The device is a hyperbaric chamber used to administer 100% oxygen at higher than ambient pressure for treating various medical conditions. It is a therapeutic device, not a diagnostic one, as it does not diagnose, detect, or identify diseases or conditions.
No
The device description clearly outlines a physical hyperbaric chamber with mechanical and pneumatic systems, pressure vessels, and control panels, indicating it is a hardware device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Sechrist Hyperbaric Chambers are designed to administer 100% oxygen at increased pressure to a patient inside the chamber. This is a therapeutic treatment applied directly to the patient's body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Sechrist Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers are medical devices used for in-vivo treatment, not in-vitro diagnosis.
N/A
Intended Use / Indications for Use
The intended use of the Sechrist Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers are to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure.
Specific indication for use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigations in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers. These thirteen indications have been recommended for third-party reimbursements and most insurance carriers have established reimbursement policy based on these recommendations.
The thirteen indications are:
- Air or Gas embolism
- Carbon Monoxide Poisoning
- Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
- Decompression Sickness
- Arterial Insufficiencies
- Central Retinal Artery Occlusion
- Enhancement of Healing In Selected Problem Wounds
- Severe Anemia
- Intracranial Abscess
- Necrotizing Soft Tissue Infections
- Osteomyelitis (Refractory)
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
- Compromise Grafts and Flaps
- Thermal Burns
Product codes (comma separated list FDA assigned to the subject device)
CBF
Device Description
A hyperbaric oxygen chamber is a pressure vessel and control system that is designed to provide patient exposure to a very high oxygen concentration at higher than normal atmospheric pressure. Titration of the oxygen exposure is controlled by selecting the pressure achieved within the pressure vessel. Pressurization and de-pressurization rates are selected to minimize patient discomfort while increasing and decreasing the chamber pressure. Typical monoplace chambers are capable of pressurizing to 3 ATA (29.4 psig above atmospheric pressure). The typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute.
The Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers are monoplace pressure chambers designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psig) of pressure. These hyperbaric chambers consist of a mechanical and pneumatic system capable of controlling the operator defined pressurization profiles.
These Hyperbaric Chambers are constructed with a horizontal seamless acrylic viewport which varying internal diameter sizes.
| Models | Internal Diameter |
|---|---|
| 3300H/HR Hyperbaric Chambers | 32.50 inches (83 cm) |
| 3600H/HR Hyperbaric Chambers | 35.50 inches (90 cm) |
Each model is equipped with a clear anodized aluminum cover on one end and the other end with a hard anodized door assembly, with access ports available for patient interface (such as patient monitoring, delivery of intravenous fluids, etc.) locking mechanism and interlocking safety device.
The cylinder, end cover and the door assembly are assembled together with stainless steel tie rods/nuts and hinge assembly. Each Hyperbaric Chamber Model comes in two configurations designated with a suffix of "H" and "HR". The suffix "H" is the Standard configuration where the control panel is located on the left of the chamber when facing the door and the door opens from left to right. The suffix "HR" is the Reverse configuration where the control panel is located on the right side of the chamber and the door opens from right to left.
The functional performance system and the safety features incorporated in the Models 3300H/HR and 3600H/HR Hyperbaric Chambers are the same that have been incorporated into the design of the Model 4100H/HR predicate device.
A pressurization cycle counter is provided to maintain a record of the number of pressurization cycles the chamber experienced.
A two-way intercommunication system is used to maintain contact between patient and attendant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The testing and performance evaluation involved validating design changes based on a risk analysis. This included system design validation, ASME Boiler & Pressure Vessels Code Section VIII Division 1 compliance, PVHO-1 Safety Standard for Pressure Vessels for Human Occupancy testing, and activation pressure verification for relief valves. Additionally, functional performance of the gas supply flow rate was verified after calibration.
The Model 4100H/HR Hyperbaric Chamber was considered the worst-case scenario for testing.
The validation data indicates the modifications made to the Model 4100H/HR Hyperbaric Chamber (predicate) resulting in the two new Hyperbaric Chamber Models 3300H/HR and 3600H/HR does not affect the Models 3300H/HR and 3600H/HR performance to meet the approved product specifications and these perform as well as and as safe as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5470 Hyperbaric chamber.
(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Sechrist Industries, Inc. The word "SECHRIST" is written in large, bold, black letters above a globe. Below the globe, the words "INDUSTRIES, INC." are written in smaller, black letters.
MAY 3 0 2014
510(k) Summary
April 25, 2014 Date Prepared
1. Submitter Device Information
| 510(k) Owners Name | Sechrist Industries, Inc.
4225 E. La Palma Avenue
Anaheim, Ca 92807
Phone: 714-579-8400 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Victor C. Arellano
Director Regulatory Affairs, Product Safety & Certification
Phone: 714-579-8344
Fax: 714-579-8393
email: VArellano@SechristUSA.com |
2. Device Information
| Trade/Proprietary Name | Model 3300H/HR Monoplace Hyperbaric Oxygen
Chamber
Model 3600H/HR Monoplace Hyperbaric Oxygen
Chamber |
|------------------------|----------------------------------------------------------------------------------------------------------------|
| Device Common Name | Monoplace Hyperbaric Chamber |
| Classification Name | Hyperbaric Chamber (21 CFR 868.5470, Product Code
CBF) |
3. Predicate Device Information
Legally marketed device to which we are claiming equivalence is the Sechrist Model 4100H/HR Hyperbaric Chamber originally cleared under 510(k) K100268
4. General Description
A hyperbaric oxygen chamber is a pressure vessel and control system that is designed to provide patient exposure to a very high oxygen concentration at higher than normal atmospheric pressure. Titration of the oxygen exposure is controlled by selecting the pressure achieved within the pressure vessel. Pressurization and de-pressurization rates are selected to minimize patient discomfort while increasing and decreasing the chamber pressure. Typical monoplace chambers are capable of pressurizing to 3 ATA (29.4 psig above atmospheric pressure). The typical pressurization and de-pressurization rates are in the range of 0.4 to 5.0 psig/minute.
4225 E. La Palma Avenue · Anaheim, California 92807 Telephone (714) 579-8400 •Fax (714) 579-0814 • Website www.sechristusa.com
1
The Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chambers are monoplace pressure chambers designed to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psig) of pressure. These hyperbaric chambers consist of a mechanical and pneumatic system capable of controlling the operator defined pressurization profiles.
These Hyperbaric Chambers are constructed with a horizontal seamless acrylic viewport which varying internal diameter sizes.
| Models | Internal Diameter |
|---|---|
| 3300H/HR Hyperbaric Chambers | 32.50 inches (83 cm) |
| 3600H/HR Hyperbaric Chambers | 35.50 inches (90 cm) |
Each model is equipped with a clear anodized aluminum cover on one end and the other end with a hard anodized door assembly, with access ports available for patient interface (such as patient monitoring, delivery of intravenous fluids, etc.) locking mechanism and interlocking safety device.
The cylinder, end cover and the door assembly are assembled together with stainless steel tie rods/nuts and hinge assembly. Each Hyperbaric Chamber Model comes in two configurations designated with a suffix of "H" and "HR". The suffix "H" is the Standard configuration where the control panel is located on the left of the chamber when facing the door and the door opens from left to right. The suffix "HR" is the Reverse configuration where the control panel is located on the right side of the chamber and the door opens from right to left.
The functional performance system and the safety features incorporated in the Models 3300H/HR and 3600H/HR Hyperbaric Chambers are the same that have been incorporated into the design of the Model 4100H/HR predicate device.
A pressurization cycle counter is provided to maintain a record of the number of pressurization cycles the chamber experienced.
A two-way intercommunication system is used to maintain contact between patient and attendant.
2
5. Statement of Intended Use
The intended use of the Sechrist Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers are to administer 100% oxygen at pressure greater than ambient, up to 3 atmospheres absolute (30 psi) of pressure.
Specific indication for use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of the Undersea and Hyperbaric Medical Society (founded in 1967 to foster exchange of data on the physiology and medicine of commercial and military diving). The committee is comprised of practitioners and scientific investigations in the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic surgery and aerospace medicine. The committee is responsible for continually reviewing research and clinical data in determining the safety and efficacy of hyperbaric oxygen. Currently, there are thirteen indications that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in vitro studies that demonstrate effectiveness, controlled animal studies, prospective controlled clinical studies and extensive clinical experience from multiple hyperbaric medicine centers. These thirteen indications have been recommended for third-party reimbursements and most insurance carriers have established reimbursement policy based on these recommendations.
The thirteen indications are:
- Air or Gas embolism 1.
-
- Carbon Monoxide Poisoning
Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
-
- Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemia's 4.
- ನ. Decompression Sickness
6. Arterial Insufficiencies
Central Retinal Artery Occlusion
Enhancement of Healing In Selected Problem Wounds
-
- Severe Anemia
- Intracranial Abscess 8.
- ರು Necrotizing Soft Tissue Infections
-
- Osteomyelitis (Refractory)
-
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
-
- Comprised Grafts and Flaps
-
- Thermal Burns
3
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 6.
CHAMBER CONTROLS 6.1.
The Models 3300H/HR and 3600H/HR Hyperbaric Chambers both use the same control panel knobs and switches as used in the predicate device 4100H/HR.
Following is description of the chamber controls.
6.1.1. Master Valve
This is a rotary pneumatic valve with three positions. The available positions allow the operator to select the following modes.
- a) Vent
- p) Off
- c) On
Specification
- a) Valve Type: 3-position pneumatic valve rotary selector
- b} Function Positions: ON, OFF, Emergency Vent
- Operating Pressure: 50 70 psig c)
6.1.2. OFF Mode
When the Master Valve is in OFF mode, the hyperbaric chamber will not be capable of developing internal pressure, and the door can be opened and closed.
6.1.3. ON Mode
The ON mode shall not be capable of operation unless the chamber door is closed and in the locked position. When the Master Valve is in ON mode, the hyperbaric chamber shall automatically start developing internal pressure (compressing) up to the Pressure Set point and at a rate established by the Rate Set control provided the door is closed and the Door Safety Interlock is engaged. The chamber door cannot be unlocked if there is more than approximately 1 psig pressure within the hyperbaric chamber.
6.1.4. Emergency Vent Mode
The Emergency Vent Mode allows the operator to depressurize the hyperbaric chamber rapidly to gain rapid access to the patient in an emergency situation. To activate the Emergency Vent, the Emergency Vent Mode is first selected via the Master Valve and the pneumatic push button manually depressed to actuate pneumatic valves to accomplish a decompression at a maximum rate of 30 psig/min.
Specification
| (a) Control Type: | Pneumatic push-button |
|---|---|
| (b) Time: | 30 psig to 0 psig in 119 sec max |
Page 4 of 20
4
6.1.5. Ventilation (Purge) Flow Rate Control
The Ventilation Flow Rate Control allows the operator to adjust the purge flow rate at which gas exhausts from the hyperbaric chamber during treatment. During treatment, once the chamber reaches desired pressure and oxygen concentration, the high ventilation rate may not be necessary and so to conserve oxygen, flow rate can be reduced. This range is clearly marked near the control valve.
Specification
| (a) Control Type: | Single Turn Gate Valve |
|---|---|
| (b) Ventilation (Purge) Flow Rate: | 80 to 400 lpm min @ 15 psig Chamber Pressure |
| (c) O2 Conservation Range: | 80 to 200 lpm |
| (d) Tolerance: | $[ \pm ]$ 50 lpm of setting |
6.1.6. Pressure Set Control
The desired hyperbaric chamber pressure is adjusted by the rotary Set Pressure Control knob.
Specification
| (a) Control Type: | Multi-turn, rotary regulating valve |
|---|---|
| (b) Range: | 1.5 to 30.0 psig or equivalent units |
| (c) Idle/Default Pressure: | 1.5 psig or equivalent units |
| (d) Resolution: | 0.2 psig or equivalent units |
| (e) Tolerance: | ± 0.5 psig of setting |
6.1.7. Rate Set Control
The desired pressurization/depressurization rate of the hyperbaric chamber is adjusted by a rotary Rate Set Control knob. The Rate Set is the rate required to reach the desired hyperbaric chamber pressure. The pneumatic system is capable of developing the Set Rate of pressure change within the chamber on a 1:1 ratio.
Specification
| (a) Control Type: | Single-turn, rotary valve |
|---|---|
| (b) Range: | 1.0 to 5.0 psig/min |
| (c) Profile: | Linear |
| (d) Resolution: | 1.0 psig/min |
| (e) Tolerance: | 20% or 0.5 psig/min of setting at range 1.0 to 3.9 |
| psig/min & 40% of setting at range 4.0 to 5.0 psig/min |
6.1.8. Intercom
The intercom sub-system is an intercommunication system for two-way private conversation capability between the patient inside the hyperbaric chamber and an attendant outside. It is capable of delivering a single channel (mono) or dual channel (stereo) audio input to the speaker inside the hyperbaric chamber for patient entertainment from an auxiliary source such as but not limited to tape
5
recorder, cd/mp3 player, DVD player and television. If the handset is picked up for conversation, the auxiliary audio signal shall be temporarily disabled.
Specification
| (a) Supply: | 12 VDC nominal |
|---|---|
| (b) Audio Power: | $1\frac{1}{2}$ watt max inside chamber |
| (c) Speakers: | Dual 4 ohms or 8 ohms, internal and external |
| (d) Internal Microphone: | Electret Condenser type or equivalent |
| (e) Volume Controls: | Rotary potentiometers for Volume In & Out CW to increase; CCW to decrease |
| (f) Aux. Input Connector: | (2) RCA Phone Jacks or equivalent |
| (g) Operator Handset: | Telephone Style or equivalent |
| (h) Indicators: | (2) LEDs |
| 1st LED: Green - Main Power ON | |
| Black - Main Power OFF | |
| 2nd LED: Amber – Low Battery Power |
MEASURED DISPLAYS 6.2.
6.2.1. Chamber Set Pressure Display
A pneumatic pressure gauge having multiple scales is installed to display the set pressure.
Specification
| (a) | Display Type: | Pneumatic Pressure Gauge |
|---|---|---|
| (b) | Display Range: | 0 to 30 psig |
| Nominal, 1.5, 2.0, 2.5, 3.0 ATA | ||
| 0 to 200 kpa (optional) | ||
| (c) | Tolerance: | ±5% of reading |
6.2.2. Chamber Actual Pressure Display
A pneumatic pressure gauge having multiple scales is installed to display actual , hyperbaric chamber pressure.
Specification
| (a) Display Type: | Pneumatic Pressure Gauge | |
|---|---|---|
| (b) Display Range: | 0 to 30 psig | |
| Nominal, 1.5, 2.0, 2.5, 3.0 ATA | ||
| 0 to 200 kpa (optional) | ||
| (c) Tolerance: | ±5% of reading |
6
Chamber Pressure Cycle Counter 6.2.3.
A pressure cycle counter is installed to record the total number of hyperbaric chamber pressurization cycles. The pressure cycle counter can be used to keep track of periodic maintenance requirements of the chamber.
Specification
| (a) Display Type: | Pneumatic Mechanical Counter |
|---|---|
| (b) Range: | 0 to 99,999 cycles min |
- (c) Reset: None
6.3. INDICATORS
6.3.1. Supply Pressure Indicator
An indicator is provided to indicate the existence of the supply pressure.
Specification
| (a) Indicator Type: | Pneumatically operated
Green to indicate supply ON
Black to indicate supply OFF |
| --------------------- | --------------------------------------------------------------------------------------- |
|---|
6.3.2. Chamber Pressure Indicator
An indicator is provided to indicate the existence of the hyperbaric chamber pressure.
Specification
| (a) Indicator Type: | Pneumatically operated |
|---|---|
| Red to indicate chamber pressure of ~ 1.5 psig or higher | |
| Black to indicate chamber pressure less than 0.5 psig |
SAFETY SYSTEMS 6.4.
6.4.1. Door Safety Interlock System
The door Safety Interlock System prevents the hyperbaric chamber door from being accidentally opened while the hyperbaric chamber is pressurized. It also prevents the pressurization of the hyperbaric chamber if the door is not in the fully locked position.
Specification
- (a) Activation pressure: approximately 1.0 psig
- (b) Deactivation pressure: approximately 0.5 psig
6.4.2. Over-Pressure Relief System
7
Two over-pressure relief valves are installed to prevent hyperbaric chamber from exceeding its maximum allowable working pressure. If the relief valve malfunctions and causes rapid decompression of the hyperbaric chamber pressure, the Manual Shut-Off Valve is also be available to prevent the rapid decompression.
3300H/HR:
| (a) Relief Valve Set Pressure: | 35 psig maximum |
|---|---|
| (b) Tolerance: | ±2 psig |
| (c) Manual Shut-Off Valve: | Sealed open with a soft wire seal |
3600H/HR:
| (a) Relief Valve Set Pressure: | 36 psig maximum |
|---|---|
| (b) Tolerance: | $\pm$ 2 psig |
| (c) Manual Shut-Off Valve: | Sealed open with a soft wire seal |
6.4.3. Emergency Shutoff and Automatic Vent
The Emergency Shutoff system allows the operator to automatically shut off the gas supply and depressurizes the hyperbaric chamber. This system is activated using a toggle switch protected by a cover to prevent accidental activation.
Specification
| (a) Control Type: | Pneumatic Toggle Switch |
|---|---|
| (b) Decompression Time: | 30 psig to 0 psig in 119 sec max |
8
TABLE OF COMPARISON 7.
There are no changes in the intended use and there are no significant changes in performance specifications or principal of operation of the Models 3300H/HR and 3600H/HR Hyperbaric Chambers, as compared to the predicate device Sechrist Model 4100H/HR Hyperbaric Chamber. Existing technology, consistent with that used in comparative chambers, has been incorporated inito the design of this device.
Modifications made to the device do not affect the intended use or alter the fundamental scientific technology of the device. Therefore, the modified device is substantially equivalent to the cleared device.
| Description | Model 4100H/HR
(Predicate) | Model 3600H | Model 3300H |
|-------------------------------------------|----------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------|
| Operational Control | | | |
| | Pneumatic Only | No Change | No Change |
| Modes | | | |
| Emergency Vent | Included | No Change | No Change |
| Off | Included | No Change | No Change |
| ON | Included | No Change | No Change |
| Emergency Shutoff and
Automatic Vent | Included | No Change | No Change |
| Displays | | | |
| Chamber Pressure Gauge | Mechanical Gauge | No Change | No Change |
| Pressure Set Gauge | Mechanical Gauge | No Change | No Change |
| Pressure Cycle Counter | Mechanical/Pneumatic
type | No Change | No Change |
| Alarms/Indicators | | | |
| Supply Pressure Indicator | Pneumatic | No Change | No Change |
| Chamber Pressure Indicator | Pneumatic | No Change | No Change |
| AC Power Indicator | LED | No Change | No Change |
| Battery Charging Indicator | LED | No Change | No Change |
| Low Battery Warning/Caution | LED | No Change | No Change |
| Accessories | | | |
| Intercom System | Included | No Change | No Change |
| Purge Rate Adjustment | Included | No Change | No Change |
| Materials | | | |
| | Aluminum | No Change | No Change |
| | Stainless Steel | No Change | No Change |
| Pressure bearing Materials | Alloy Steel | No Change | No Change |
| | Acrylic | No Change | No Change |
| Description | Model 4100H/HR
(Predicate) | Model 3600H | Model 3300H |
| Specifications | | | |
| Maximum Operating Pressure | 30.0 psig
3.0 ATA
2.1 kg/cm²
206.8 kPa at ambient | No Change | No Change |
| Operating Temperature Range | 50° - 100° F
(10°- 38° C) | No Change | No Change |
| Operating Humidity Range | 30% to 90% at 77° F | No Change | No Change |
| Supply Pressure | 50.0 to 70.0 psig
(3.5 to 4.9 kg/cm²)
(344.8 to 482.7 kPa) | No Change | No Change |
| Supply Pressure Flow Rate | 42 SCFM | 34 SCFM | 32 SCFM |
| Rate Set | 1- 5.0 psig/min | No Change | No Change |
| Pressure Set | 1.5 - 30 psig | No Change | No Change |
| Purge Rate | 80 to 400 LPM with the chamber pressure set at 15 psig | No Change | No Change |
| Emergency Vent Rate | 30 psig to 0 psig in 119 seconds maximum
(0.25 - 0.5 psig/second) | No Change | No Change |
| Relief valves | Quantity (2)
Set at 36.00 psig | Quantity (2)
Set at 36.00 psig | Quantity (2)
Set at 35.00 psig |
| Electrical Power | | | |
| A.C. Input range | 90 to 264 VAC | No Change | No Change |
| A.C. Input Frequency | 47 to 33 Hz | No Change | No Change |
| D.C Output Voltage | +12 VDC Nominal | No Change | No Change |
| D.C. Output Current | 3.3 A Maximum | No Change | No Change |
| Cylinder Dimensions (reference Drawing A) | | | |
| Cylinder Internal Diameter | 41.00 Inches
(104 cm) | 35.50 Inches
(83 cm) | 32.50 Inches
(90 cm) |
| Internal Length | 91.00 Inches
(231 cm) | 91.00 Inches
(231 cm) | 91.00 Inches
(231 cm) |
| External Length(A) | 106.00 Inches
(269 cm) | 106.00 Inches
(269 cm) | 106.00 Inches
(269 cm) |
| External Height (B) | 69.75 Inches
(177 cm) | 63.00 Inches
(160 cm) | 59.00 Inches
(150 cm) |
| External Width (C) | 46.75 Inches
(119 cm) | 44.50 Inches
(113 cm) | 44.50 Inches
(113 cm) |
| Chamber Weight | 3,500 lbs
(1591 kg) | 2,220 lbs
(1009 kg) | 2,030 lbs
(923 kg) |
| Supported Patient Weight | 700 lbs standard
(318 kg) | 700 lbs standard
(318 kg) | 500 lbs standard
(227 kg);
700 lbs optional
(318 kg) |
The chart below compares the modifications listed above to the predicate device.
Page 9 of 20
9
510(K) SUMMARY
SPECIAL 510(K) PREMARKET NOTIFICATION
3300H/HR and 3600H/HR Hyperbaric Chamber
・
Page 10 of 20
10
510(K) SUMMARY
SPECIAL 510(K) PREMARKET NOTIFICATION
3300H/HR and 3600H/HR Hyperbaric Chamber
Image /page/10/Figure/1 description: The image shows a technical drawing of a machine with dimensions labeled. The overall length of the machine is labeled as 193.0 inches or 4.9 meters. The drawing also includes labels A, B, and C, which likely represent other key dimensions of the machine, but the specific values for these dimensions are not provided in the image.
Drawing A
11
DETERMINATION OF SUBSTANTIAL EQUIVALENCE 8.
Summary of Technological Changes
Similarities
The modifications made to the existing Model 4100H/HR Hyperbaric Oxygen Chamber do not affect the indications for use or theory of operation, and do not change the hyperbaric pressure technology used in the design of the chamber. There has been no change in the science involved with providing hyperbaric oxygen therapy in a monoplace chamber. The weight and dimensions of the two models created by the change are decreased due to the reduction in the size of the acrylic viewport window and pressure retaining metal components. The pressure bearing components and materials have not been changed and comply with the ASME Boiler & Pressure Vessels Code Section VIII Division 1 and ASME PVHO-1 Safety Standard for Pressure Vessels for Human Occupancy. The control panel used for each model is the same as found on the Model 4100H/HR Hyperbaric Chamber with the operational controls remaining the same.
The pressure related safety features of the two Models 3300H/HR and 3600H/HR Hyperbaric Chambers, including the door interlock system, and the door safety switch have not been changed from the Model 4100H/HR Hyperbaric Chamber.
Differences (Changes)
The only changes to the Model 4100H/HR resulting in the two Models 3300H/HR and 3600H/HR Hyperbaric Chambers are as follows:
A. Acrylic Cylinder Size
Model 3600H/HR Hyperbaric Chamber
This Hyperbaric Chamber model has a smaller internal diameter, external height and external width when compared to the Model 4100H/HR Hyperbaric Chamber (predicate). These difference in sizes from the Model 4100H/HR Hyperbaric Chamber (predicate device) can be seen in the Engineering Drawings (see Section 12 - Attachment A).
| Cylinder Internal Diameter | 41.00 Inches (104 cm) | 35.50 Inches (83 cm) |
|---|---|---|
| External Height (B) | 69.75 Inches (177 cm) | 63.00 Inches (160 cm) |
| External Width (C) | 46.75 Inches (119 cm) | 44.50 Inches (113 cm) |
| Chamber Weight | 3,500 lbs (1591 kg) | 2.220 Ibs (1009 kg) |
12
- · The effects of the modification to this model (i.e., smaller cylinder internal diameter, external height and external widths) results in a reduction of the overall chamber weight when compared to that of the predicate device. This reduction in cylinder size does not affect the operation of the device and its ability to function to the same specifications as the predicate device.
Model 3300H/HR Hyperbaric Chamber
This Hyperbaric Chamber model has a smaller internal diameter, external height and external width when compared to the Model 4100H/HR Hyperbaric Chamber (predicate). These difference in sizes from the Model 4100H/HR Hyperbaric Chamber (predicate device) can be seen in the Engineering Drawings (see Section 12 - Attachment A).
| Description | Model 4100H/HR
(Predicate) | Model 3300H |
|----------------------------|-------------------------------|-----------------------|
| Cylinder Internal Diameter | 41.00 Inches (104 cm) | 32.50 Inches (90 cm) |
| External Height (B) | 69.75 Inches (177 cm) | 59.00 Inches (150 cm) |
| External Width (C) | 46.75 Inches (119 cm) | 44.50 Inches (113 cm) |
| Chamber Weight | 3,500 lbs (1591 kg) | 2,030 lbs (923 kg) |
The effects of the modification to this model (i.e., smaller cylinder internal diameter, external height and external widths) results in a reduction of the overall chamber weight when compared to that of the predicate device.
B. Relief Valve
This Hyperbaric Chamber model has two over-pressure relief valves installed to prevent the hyperbaric chamber from exceeding its maximum allowable working pressure which is the design pressure. However, the maximum working pressure is still limited to 30 psi or 3 ATA. The Model 3300H/HR has a setting that differs from the predicate device while the Model 3600H/HR has the same setting as the predicate device. The pressure setting of this model is the same as a previous device (Model 3200) for which the 3300H/HR will eventually replace.
| Description | Model 4100H/HR
(Predicate) | Model 3600H | Model 3300H |
|---------------|-----------------------------------|-----------------------------------|-----------------------------------|
| Relief valves | Quantity (2)
Set at 36.00 psig | Quantity (2)
Set at 36.00 psig | Quantity (2)
Set at 35.00 psig |
13
Gas Supply Flow rate C.
The Hyperbaric Chamber requires a gas supply source with a flow rate measured in standard cubic feet per minute (SCFM) units capable of supplying a gas supply pressure within a range of 50-70 psig. The required SCFM is based on the volume requirements during peak flow conditions for each model Hyperbaric Chamber.
The typical treatment cycle of a hyperbaric chamber consists of three phases:
-
- Peak Flow defined as increase from ambient to the prescribed treatment pressure at worst condition.
-
- Steady Flow defined as pressure hold at treatment level.
-
- Minimum Flow defined as exhaust from treatment pressure to ambient.
The required Gas Supply Flow Rates for the Models 3600H/HR and 3300H/HR Hyperbaric Chambers as compared to the predicate model is provided in the table below. The table illustrates the flow rates required for the Model 3600H/HR and Model 3300H/HR are lower than the predicate device Model 4100H/HR Hyperbaric Chamber.
| Description | Model 4100H/HR
(Predicate) | Model 3600H/HR | Model 3300H/HR |
|----------------------|-------------------------------|----------------|----------------|
| Gas Supply Flow Rate | 42 SCFM | 34 SCFM | 32 SCFM |
14
TESTING & PERFORMANCE EVALUATION ਰੇ
The Table below summarizes the tests required to validate/verify design changes based on the risk analysis. Design Validation & Verification, Electrical Safety/EMC and Performance test reports are provided in Appendix VIII.
| Device Change | Device Requirement
Reference | Testing Performed | Acceptability
Criteria | Test
Reference |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------|---------------------------------------------|
| | Device specification | System Design Validation | Performs to
requirements | 2009-0010 |
| Decreased
Acrylic Window
Size, Length and
Width | ASME Authorized Pressure
Vessel Facility | ASME Boiler & Pressure
Vessels Code Section VIII
Division 1 | ASME
Authorization | ASME "U"
Certificate of
Authorization |
| | PVHO-1 Pressure Bearing
Testing | PVHO-1 Safety Standard for
Pressure Vessels for Human
Occupancy | Tested at 1.1 x
MAWP | PVHO-1
Appendix I,
Enclosure 4 |
| Over Pressure
Relief valve
pressure
change | 1. Device Specification
2. Final Test and
Calibration Procedures
Model 3300H/HR,
3600H/HR, 4100H/HR
Series | 1. System Design Validation
2. Activation pressure of
valves | Performs to
requirements | Document
No. 150156,
Section 5 |
| Gas supply
flow rate | 1. Device Specification
2. Final Test and
Calibration Procedures
Model 3300H/HR,
3600H/HR, 4100H/HR
Series | 1. System Design Validation
2. Device performs to
specification after
calibration. | Performs to
requirements | 1. 2009-0010
2. Doc. No.
150156 |
SYSTEM VALIDATION MATRIX
DETAILED DESCRIPTION OF MODIFICATIONS 10.
The modifications resulting in the Model 3300H/HR Hyperbaric Chamber and Model 3600H/HR Hyperbaric Chamber as compared with the Model 4100H/HR Hyperbaric Chamber (predicate) are provided in the following sections and associated tables.
10.1. Smaller Acrylic Cylinder Size
Design Requirement:
The internal diameter of the Model 3300H/HR acrylic cylinder was decreased to 32.50 inches and the internal diameter for the Model 3600H/HR acrylic cylinder was decreased to 35.50 inches from the internal diameter of 41.0 inches of the Model 4100H/HR (predicate device) to provide the most commonly used size of chamber for the most common patient population size on the market and reduce the space necessary to house the hyperbaric chambers.
Design Modification:
The decrease in the internal diameter of the cylinder from 41.0 inches (Model 4100H/HR) to 32.50 inches (Model 3300H/HR) was made to meet customer requests for a Hyperbaric
15
Chamber that would accommodate the most common patient size and weight seeking clinical treatment in the market and reduce the space necessary to house the hyperbaric chambers. The reduction in the internal diameter also resulted in reduction of external height and width of the cylinder.
Hazard / Risk:
Change does not pose a risk to the operator or patient.
Validation:
The decrease in acrylic viewport size was validated by testing the Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers ability to operate to their approve product specifications. The data indicates the change does not affect the devices ability to perform to its product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device).
| Item | Description | Model 4100H/HR
(Predicate) | Model 3600H | Model 3300H |
|------|----------------------------|-------------------------------|--------------------------|--------------------------|
| 1 | Cylinder Internal Diameter | 41.00 Inches
(104 cm) | 35.50 Inches
(83 cm) | 32.50 Inches
(90 cm) |
| 2 | External Height (B) | 69.75 Inches
(177 cm) | 63.00 Inches
(160 cm) | 59.00 Inches
(150 cm) |
| 3 | External Width (C) | 46.75 Inches
(119 cm) | 44.50 Inches
(113 cm) | 44.50 Inches
(113 cm) |
10.2. Relief Valve Pressure Change
Design Requirement:
The Relief Valve Pressure for the Model 3300H/HR Hyperbaric Chamber was changed to 35 psig from the pressure of 36 psig offered on the predicate device Model 4100H/HR Hyperbaric Chamber (predicate device). This change was made to offer the same pressure relief option as the Sechrist Model 3200 released by 510(k) K950386.
The Relief Valve Pressure for the Model 3600H/HR Hyperbaric Chamber remains unchanged from the Model 4100H/HR Hyperbaric Chamber (predicate device).
Design Modification: .
The Relief Valves relief pressure was adjusted by the supplier to trigger at 35 psig ± 2 psig.
Hazard / Risk:
The identified hazard of excessive chamber pressure could potentially result in patient barotrauma risk. The identified hazard of chamber pressurization exceeding design pressure could potentially result in catastrophic structural failure risk.
16
Validation
The activation of the Relief Valve Pressure validated by testing the Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers ability to activate the Relief Valves at their respective preset activation pressures. Each Relief Valve is tested prior to installation during the manufacturing of the Hyperbaric Chamber. . This data is recorded in the "Final Test and Calibration Procedures Model 3300H/HR, 3600H/HR, 4100H/HR Series" (Document 150156).
The data indicates that the Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers activates the Relief Valves at the activation pressures as outlined in the product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device).
| .Item | Description | Model 4100H/HR
(Predicate) | Model 3600H | Model 3300H |
|-------|------------------------------------------------|-------------------------------|------------------|------------------|
| 1 | Relief Valve Pressure
(activation pressure) | 36 psig ± 2 psig | 36 psig ± 2 psig | 35 psig ± 2 psig |
10.3. Gas Supply Flow Rate Change
The Hyperbaric Chamber requires a gas supply source with a flow rate measured in standard cubic feet per minute (SCFM) units capable of supplying a gas supply pressure within a range of 50-70 psig. The required SCFM is based on the volume requirements during peak flow conditions for each model Hyperbaric Chamber.
The typical treatment cvcle of a hyperbaric chamber consists of three phases:
-
- Peak Flow defined as increase from ambient to the prescribed treatment pressure.
-
- Steady Flow defined as pressure hold at treatment level.
-
- Minimum Flow defined as exhaust from treatment pressure to ambient.
The required Gas Supply Flow Rates for the Models 3600H/HR and 3300H/HR Hyperbaric Chambers as compared to the predicate model is provided in the table below.
| Description | Model 4100H/HR
(Predicate) | Model 3600H | Model 3300H |
|----------------------|-------------------------------|-------------|-------------|
| Gas Supply Flow Rate | 42 SCFM | 34 SCFM | 32 SCFM |
Design Requirement:
The Gas Supply Flow Rate for the Model 3300H/HR Hyperbaric Chamber was reduced to 32 SCFM from the predicate device of 42 SCFM. The Model 3600H/HR Hyperbaric Chamber Gas Supply Flow Rate was also reduced to 34 SCFM from the predicate device of 42 SCFM. The SCFM required to operate each device is based on the volume requirements of each Hyperbaric Chamber model. The Gas Supply Flow Rate required during peak flow conditions is used to establish the minimum SCFM for each model.
17
Design Modification:
The Model 3600H/HR and the Model 3300H/HR Hyperbaric Chamber have a lower volume than the Model 4100H/HR Hyperbaric Chamber (predicate device). The Model 3600H/HR requires 34 SCFM to ensure operation to its approved specifications and Model 3300H/HR Hyperbaric Chamber requires 32 SCFM to ensure operation to its approved specifications.
Hazard / Risk:
The identified potential hazard of fluctuations in gas supplies may lead a risk of the inability to compress Hyperbaric Chamber.
Validation
The decrease in Gas Supply Flow Rates were validated by testing the Model 3300H/HR and Model 3600H/HR Hyperbaric Chambers ability to operate to their approve product specifications. Each model is tested 100% using the recommended supply pressure settings during manufacturing to ensure it will perform to its approved specification. This data is recorded in the "Final Test and Calibration Procedures Model 3300H/HR, 3600H/HR, 4100H/HR Series" (Document 150156). The data indicates the change does not affect the devices ability to perform to its product specifications and performs equivalently to the Model 4100H/HR Hyperbaric Chamber (predicate device).
| Item | Description | Model 4100H/HR
(Predicate) | Model 3600H | Model 3300H |
|------|----------------------|-------------------------------|-------------|-------------|
| 1 | Gas Supply Flow Rate | 42 SCFM | 34 SCFM | 32 SCFM |
18
11. VALIDATION / VERIFICATION MEASURES:
The device modification found in the Model 3300H/HR Hyperbaric Chamber and Model 3600H/HR Hyperbaric Chamber are provided in Attachment A.
The Models 3300H/HR and 3600H/HR Hyperbaric Chambers vary in acrylic viewport size and pressure retaining metal components. The control system, piping and performance specifications did not change nor have an impact on the functionality of the device from the Model 4100H/HR Hyperbaric Chamber. The validation documents tested the worstcase scenario which is the larger Model 4100H/HR Hyperbaric Chamber. Functionality of the Models is tested during production as a condition of release.
The Model 4100H/HR Hyperbaric Chamber is considered the worst-case scenario
| Device Change | Risk Analysis
Reference | Device
Requirement
Reference | Testing
Performed | Acceptability
Criteria | Test Reference |
|-------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------|---------------------------------------------|
| Decreased
Acrylic
Window Size,
Length and
Width | Items 1, 2, 3 | Device
specification | System Design
Validation | Performs to
requirements | 2009-0010 |
| | | ASME
Authorized
Pressure Vessel
Facility | ASME Boiler &
Pressure
Vessels Code
Section VIII
Division 1 | ASME
Authorization | ASME "U"
Certificate of
Authorization |
| | | PVHO-1
Pressure
Bearing Testing | PVHO-1 Safety
Standard for
Pressure
Vessels for
Human
Occupancy | Tested at 1.1 x
MAWP | PVHO-1
Appendix 1,
Enclosure 4 |
| Over Pressure
Relief valve
pressure
change | Item 1 | Device
specification | System Design
Validation | Performs to
requirements | 2009-0010 |
| | | Final Test and
Calibration
Procedures
Model
3300H/HR,
3600H/HR,
4100H/HR
Series | Activation of
Relief Valve
verification and
Install | Performs to
requirements | Document No.
150156 |
| Gas supply
flow rate | Item 1 | Device
specification | System Design
Validation | Performs to
requirements | 2009-0010 |
| | | Final Test and
Calibration
Procedures
Model
3300H/HR,
3600H/HR,
4100H/HR
Series | Functional
performance
to specification
after
calibration. | Performs to
requirements | Document No.
150156 |
19
12. VALIDATION / VERIFICATION SUMMARY
The validation data indicates the modifications made to the Model 4100H/HR Hyperbaric Chamber (predicate) resulting in the two new Hyperbaric Chamber Models 3300H/HR and 3600H/HR does not affect the Models 3300H/HR and 3600H/HR performance to meet the approved product specifications and these perform as well as and as safe as the predicate device.
20
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2014
Sechrist Industries, Inc. Mr. Victor Arellano Director Regulatory Affairs, Product Safety & Certification 4225 East La Palma Avenue Anaheim, CA 92807
Re: K140559
Trade/Device Name: Sechrist Models 3300H/HR and 3600H/HR Hyperbaric Chamber Regulation Number: 21 CFR 868.5470 Regulation Name: Hyperbaric Chamber Regulatory Class: II Product Code: CBF Dated: April 30, 2014 Received: May 01, 2014
Dear Mr. Arellano:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary manation poor the Medical Device Amendments, or to Commerce prior to May 20, 1977) are occordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). allo Cosmetic Act (710) that to hot required to the general controls provisions of the Act. The You may, merciole, manel and nevyolyde requirements for annual registration, listing of general controls proficions practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Ticaso note: Obter See hat device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) inxisting major regulations affecting your device can be filly be subject to additional ochaons. Existing may of to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
21
Page 2 - Mr. Arellano
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part the regulation entitled, "Misoranams" of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the rou may other baller general mornemational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
(800) 030 2011 01 (30 41 01 (30 40 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit Sheth M.D. Cilnical Deputy Director
DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
22
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140559
Device Name
Sechrist Models 3300H/HR Hyperbaric Chamber Sechrist Models 3600H/HR Hyperbaric Chamber
Indications for Use (Describe)
The intended use of the hyperbaric chambers have been established by the Committee on Hyperbaric Oxygen Therapy of The Intended as of the Irportant in 1967 to foster exchange of data on the physiology and the Onucles of commercial and military diving). The committee is comprised of practitioners and scientific investigation the fields of internal medicine, infectious diseases, pharmacology, emergency medicine, general surgery, orthopedic the freits of mierner modions, incomed essent of the maxillofacial surgery and aerospace medicine. The surely, dauna surgery, and continually reviewing research and clinical data in determining the safety and efficacy of committee is responsible to continually to reville results that are approved by the committee; these thirteen indications were accepted based on sound physiologic rationale, in viro studies that demonstrate effectiveness, controlled were accepted based on some physionals, in 1778 to extensive clinical experience from multiple hyperbaric animal studies, prospective connect states and should be third-party reimbursement and most insurance carriers have established reimbursement policy based on the recommendations.
The thirteen indications are:
-
- Air or Gas embolism
-
- Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
-
- Clostridial Myonecrosis and Myonecrosis (Gas Gangrene)
-
- Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias
-
- Decompression Sickness
-
- Arterial Insufficiencies
- Central Retinal Artery Occlusion Enhancement of Healing In Selected Problem Wounds
-
- Severe Anemia
-
- Intracranial Abscess 9. Necrotizing Soft Tissue Infections
-
- Osteomyelitis (Refractory)
-
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
-
- Compromise Grafts and Flaps
-
- Thermal Burns
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
23
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