(201 days)
COWBOY Y
Not Found
No
The device description details a microprocessor controlling basic functions like pressure, cycle time, and hold time based on user input and simple pressure monitoring. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
Yes
The intended use of the device directly states benefits such as preventing DVT, reducing pain and swelling, treating ulceration, and assisting healing, all of which fall under therapeutic applications.
No
The REDOX pump is described as an intermittent pneumatic compression device that aids circulation. Its intended uses and functions are therapeutic (e.g., preventing DVT, reducing edema, enhancing circulation), not diagnostic. It does not perform any analysis or provide information about a patient's medical condition.
No
The device description clearly states it is comprised of two major components: a reusable pump unit (controller device) and a single-patient use inflatable wrap. These are hardware components, making it a hardware device with software control, not a software-only device.
Based on the provided information, the REDOX pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- REDOX Function: The REDOX pump is a pneumatic compression device that applies external pressure to the arm. It does not analyze any biological specimens.
- Intended Use: The intended uses listed are all related to applying physical compression to the arm to improve circulation and reduce swelling, not to perform diagnostic tests on samples.
- Device Description: The description details a mechanical and electrical device that inflates wraps, not a device that processes biological samples.
Therefore, the REDOX pump falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The REDOX pump is indicated for patients who would benefit from a pneumatic compression device applied to the arm. Such benefits include helping to:
- Prevent Deep Venous Thrombosis (DVT) .
- Prevent venous stasis in the upper extremities .
- . Enhance arterial circulation in the upper extremities
- Reduce post-operative pain and swelling in the upper extremities. ●
- Reduce edema in the upper extremities. .
- . Reduce wound healing time in the upper extremities
- Treat and assist healing of cutaneous ulceration in the upper extremities. .
- Reduce compartmental pressures in the upper extremities. .
- Reduce the need for anticoagulant medications prescribed for the prevention of DVT. .
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The REDOX functions as an intermittent pneumatic compression device that aids in the circulation of blood in patients with lymphedema due to mastectomy, surgery, injury or disease. The REDOX is not a life-supporting or life-sustaining device. Also, the REDOX is not an implant (short-term or long-term), nor is it a sterile device. The REDOX is an electrically-operated (see electrical testing in test section), softwaredriven (see software testing in test section), prescription device (see drawing A-205360 in labeling section), which is used in a hospital environment (see mechanical testing in test section). The REDOX is comprised of two major components -- the reusable pump unit (controller device) (see drawings C-205303, D-212032, D-212032, D-235308 in engineering drawings section) and a single-patient use inflatable wrap (see drawings D-410009, D-410008, in engineering drawings section). Neither component contains a drug nor biological product as a subcomponent.
The REDOX unit uses a 16' hospital grade power cord (see drawing B-205337 in engineering drawings section) to supply a voltage of 115 VAC at a frequency of 60Hz with a maximum current consumption of 0.33 amperes and a maximum electrical leakage of less than 100 microamps (see electrical testing in test section) from its power source. An exterior shell made of ABS material, measuring 12" long by 10 3/4" wide by 7" deep, protects the subcomponents of the REDOX 11 pound unit (see drawings D-205306, D-212032 in engineering drawings section).
The compressor inflates one or more of the wraps in minimum intervals of 10 seconds at a maximum pressure of not more than 180 mmHg (±15 mmHg).
The unit features a microprocessor (see drawing D-210528 in engineering drawings section) that controls the unit's operation. The user selects: 1) the pressure from 140 to 180 mmHg, in 10 mmHg increments; 2) the cycle time from 20 to 60 seconds, in 10 second increments, and; 3) the hold time from 1 to 5 seconds. in 1 second increments (see software testing in test section). Selections are made by the user interfacing with the membrane switch located on the front of the unit (see drawing C-205315 in engineering drawings section and drawing B-235309 in labeling section). The microprocessor also has detection capabilities to monitor the pressure in the wrap(s), adjusting the in and out flow of air on every cycle, to ensure that the target pressure is consistently maintained. If for any reason the target pressure cannot be maintained, the microprocessor alarm capabilities will activate both visual and audio alarms (see software testing in test section). These alarm capabilities are built in to detect high pressure, low pressure and/or unit malfunction situations, should they ever occur (see software testing in test section).
The non-sterile inflatable wraps are for single patient use only (see labeling section). Arm wraps (see drawings D-410009, D-410008, in engineering drawings section) are designed to fit around and compress the veins in the arm, including both collateral veins and deep veins. Hook-and-loop fasteners are used to hold the wrap comfortably around the arm. The wraps are RF-welded to create an air chamber that can then be inflated by the REDOX unit. This air chamber is what actually applies pressure against the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper extremities (arm)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital environment
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
The REDOX software test protocol involved checking if the device could maintain an average pressure in the inflatable wraps within ±15 mmHg of the target pressure throughout the entire hold time, and if it correctly activated visual and audio alarms for high pressure, low pressure, and unit malfunction. The test procedures focused on pulsation settings that gave the system the least recovery time, and also stressed the software with rapid input and operational disruptions. Tests included pulsation verification procedures for right foot wrap, left foot wrap, left & right foot wrap, right arm wrap, left arm wrap, and left & right arm wrap, each with various pressure settings (140, 160, 180 mmHg), cycle times (20-60 sec), and hold times (1-5 sec). Alarm testing procedures involved introducing low pressure (1/8" slit in bladder) and high pressure (kinking PVC hose), and unit malfunction (disconnecting PVC hose) for various wrap configurations to confirm alarm activation. Software stress tests involved rapidly changing pulsation settings and disrupting operation while a wrap was inflated to ensure correct adjustment. The tests were performed by T. Randolph on August 2, 1995, using Test Unit: 61578, with accessories wrapped around high density foam.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Nonclinical testing (pulsation verification, alarm testing, software stress test)
Key Results:
- Pulsation Verification: The results demonstrated that the device maintained pressures generally within the specified ±15 mmHg range for various settings and wrap configurations (foot wrap, arm wrap, bilateral). For example, at PS 1, CT 20, HT 1, average pressures for foot wraps ranged from 131.2 mmHg (Left) to 143.2 mmHg (Right), and for arm wraps from 140.8 mmHg (Bilateral Left) to 152 mmHg (Right). At PS 5, CT 20, HT 5, average pressures for foot wraps ranged from 179.8 mmHg (Bilateral Left) to 188.6 mmHg (Right), and for arm wraps from 179 mmHg (Left) to 187.8 mmHg (Right and Bilateral Right).
- Alarm Testing: All low pressure, high pressure, and unit malfunction alarm scenarios (right only, left only, bilateral for foot wraps and arm wraps, and hose removed for unit malfunction) resulted in alarm activation ("YES" in all tested conditions).
- Software Stress Test: All tests for rapid input and operational disrupt scenarios for foot wraps (right only, left only, bilateral) and arm wraps (right only, left only, bilateral) passed, indicating robust software performance under stress.
Overall Conclusion:
The nonclinical testing showed that the REDOX device performed within specifications for pulsation control, alarm functionalities, and resilience to rapid input/operational disruptions. The results were consistent with the predicate device, leading to the conclusion that the device is safe, effective, and performs as well as the legally marketed 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.
COWBOY Y
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.
Not Found
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
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
K9535tC
4 1996
"510(K) SUMMARY"
(Sec. 807.92 Content and format of a 510(k) summary)
SECTION 807.92 a(1)
SUBMITTER'S NAME:
KCI New Technologies Inc.
ADDRESS:
12922 Flagship San Antonio. Texas 78247
CONTACT PERSON:
William H Quirk Director of Regulatory Affairs P.O. Box 659508 San Antonio, Texas 78265
DATE:
August 18. 1995
PHONE AND FAX:
Tel: 210/225-7386 210/225-4285 Fax:
SECTION 807.92 a(2)
DEVICE NAME:
REDOX
TRADE NAME: Undetermined
COMMON NAME: Pneumatic Compression Device
CLASSIFICATION NAME: Compressible Limb Sleeve
SECTION 807.92 a(3)
PREDICATE DEVICE CLAIMING EQUIVALENCE TO:
COWBOY Y
CONFIDENTIAL
l
1
SECTION 807.92 a(4)
DEVICE DESCRIPTION: (Please note the controller device is the same controller used for the predicate device.)
The following device description is per section 3 of the draft "REVIEWER GUIDANCE FOR PREMARKET NOTIFICATION SUBMISSIONS," dated November, 1993, from the Anesthesiology and Respiratory Devices Branch and the Division of Cardiovascular, Respiratory, and Neurological Devices
The REDOX functions as an intermittent pneumatic compression device that aids in the circulation of blood in patients with lymphedema due to mastectomy, surgery, injury or disease. The REDOX is not a life-supporting or life-sustaining device. Also, the REDOX is not an implant (short-term or long-term), nor is it a sterile device. The REDOX is an electrically-operated (see electrical testing in test section), softwaredriven (see software testing in test section), prescription device (see drawing A-205360 in labeling section), which is used in a hospital environment (see mechanical testing in test section). The REDOX is comprised of two major components -- the reusable pump unit (controller device) (see drawings C-205303, D-212032, D-212032, D-235308 in engineering drawings section) and a single-patient use inflatable wrap (see drawings D-410009, D-410008, in engineering drawings section). Neither component contains a drug nor biological product as a subcomponent.
The REDOX unit uses a 16' hospital grade power cord (see drawing B-205337 in engineering drawings section) to supply a voltage of 115 VAC at a frequency of 60Hz with a maximum current consumption of 0.33 amperes and a maximum electrical leakage of less than 100 microamps (see electrical testing in test section) from its power source. An exterior shell made of ABS material, measuring 12" long by 10 3/4" wide by 7" deep, protects the subcomponents of the REDOX 11 pound unit (see drawings D-205306, D-212032 in engineering drawings section).
The compressor inflates one or more of the wraps in minimum intervals of 10 seconds at a maximum pressure of not more than 180 mmHg (±15 mmHg).
The unit features a microprocessor (see drawing D-210528 in engineering drawings section) that controls the unit's operation. The user selects: 1) the pressure from 140 to 180 mmHg, in 10 mmHg increments; 2) the cycle time from 20 to 60 seconds, in 10 second increments, and; 3) the hold time from 1 to 5 seconds. in 1 second increments (see software testing in test section). Selections are made by the user interfacing with the membrane switch located on the front of the unit (see drawing C-205315 in engineering drawings section and drawing B-235309 in labeling section). The microprocessor also has detection capabilities to monitor the pressure in the wrap(s), adjusting the in and out flow of air on every cycle, to ensure that the target pressure is consistently maintained. If
2
SECTION 807.92 a(4) con,t
for any reason the target pressure cannot be maintained, the microprocessor alarm capabilities will activate both visual and audio alarms (see software testing in test section). These alarm capabilities are built in to detect high pressure, low pressure and/or unit malfunction situations, should they ever occur (see software testing in test section).
The non-sterile inflatable wraps are for single patient use only (see labeling section). Arm wraps (see drawings D-410009, D-410008, in engineering drawings section) are designed to fit around and compress the veins in the arm, including both collateral veins and deep veins. Hook-and-loop fasteners are used to hold the wrap comfortably around the arm. The wraps are RF-welded to create an air chamber that can then be inflated by the REDOX unit. This air chamber is what actually applies pressure against the body.
3
Image /page/3/Figure/0 description: The image shows a diagram of a robotic arm control system. The diagram includes components such as manifolds and valves, a pump, a tank, and a microprocessor for feedback control. The robotic arms are labeled as "LEFT" and "RIGHT", and the diagram also indicates connections to the atmosphere, air lines, and electrical lines.
f
Image /page/3/Figure/1 description: The image shows the text "Figure A.1" vertically oriented. The word "Figure" is stacked on top of "A.1". The text is black and the background is white.
4
SECTION 807.92 a(5)
INTENDED USE:
MEDICAL INDICATIONS:
The REDOX pump is indicated for patients who would benefit from a pneumatic compression device applied to the arm. Such benefits include helping to:
- Prevent Deep Venous Thrombosis (DVT) .
- Prevent venous stasis in the upper extremities .
- . Enhance arterial circulation in the upper extremities
- Reduce post-operative pain and swelling in the upper extremities. ●
- Reduce edema in the upper extremities. .
- . Reduce wound healing time in the upper extremities
- Treat and assist healing of cutaneous ulceration in the upper extremities. .
- Reduce compartmental pressures in the upper extremities. .
- Reduce the need for anticoagulant medications prescribed for the prevention of DVT. .
MEDICAL CONTRAINDICATIONS:
Patient conditions for which the REDOX pump is contraindicated include:
- Presumptive evidence of congestive heart failure .
- . Suspected pre-existing DVT.
DIFFERENCES IN INDICATIONS:
The indications for the REDOX are the same as those for the predicate device. The only difference being application to the upper extremity versus the lower extremity.
5
SECTION 807.92 a(6)
TECHNOLOGICAL CHARACTERISTICS:
| PREDICATE DEVICE: | SUBMITTED DEVICE: | |
|---|---|---|
| COWBOY X | REDOX | |
| MAIN UNIT: | ||
| Structural Design | Portable | Same |
| Material | ABS, Aluminum | Same |
| Internal Components | Pump. Tank. | |
| Solenoid Valves | Same | |
| Power Supply | 115 VAC 60Hz .33 Amp. | Same |
| Electronics | Microprocessor | Same |
| Software | "C" Language Program | Same |
| OPERATION: | ||
| Cycle Time | 20-60 sec. | |
| (10 sec. increments) | Same | |
| Hold Time | 1-5 sec | |
| (1 sec. increments) | Same | |
| Pressure Settings | 140-180 mmHg | |
| (10 mmHg increments) | Same | |
| Pressure Readings | $\pm$ 15 mmHg | Same |
| User Interface | Yes | Yes |
| ACCESSORIES: | ||
| Foot Wrap | Yes | No |
| Arm Wrap | No | Yes |
| Material | Lycra Interior | |
| Loop Exterior | Same | |
| Manufacturing Process | Die Cutting | |
| R-F Welding | ||
| Sewing | ||
| Hot Stamping | Same | |
| Tooling | "T" Shaped | "C" Shaped |
6
: 上一
6
SECTION 807.92 b(1)
DISCUSSION OF NONCLINICAL TESTING:
SOFTWARE TEST PROTOCOL AND PROCEDURES
The test protocol for the REDOX is very simple. The REDOX software will pass if it can operate within specifications. These specifications include being able to maintain an average pressure in the inflatable wrap(s) within ±15 mmHg of target pressurethroughout the entire hold time and setting off visual and audio alarms in the event of a high pressure, low pressure, and/or unit malfunction. If for any reason any one of these specifications are not met, the software is rejected
The software test procedures for the RED()X have been designed to take advantage of our experience with the predicate device. First, we will focus on pulsation settings that will give the system the least amount of time to recover. Second, we will focus on low pressure, high pressure, and unit malfunction allarms. Finally, we will focus on stressing the software with rapid input and operational disruptions.
PULSATION VERIFICATION PROCEDURES
-
- Right Foot Wrap
- 1.1 Test pressure at the wrap per operation and maintenance manual page 6-2
- 1.2 Wrap foot wrap around a simulated foot model
- 1.3 Set pulsation settings at pressure setting 1, cycle time at 20, and hold time at 1
- 1.4 From the FOR SERVICE USE ONI.Y screen press VIEW then press HOME
- 1.5 Under RS write down the pressure reading shown on the screen for five consecutive cycles after the unit has "Ramped-up"
- 1.6 Repeat process for:
- 1.6.1 Pressure setting at 1. cycle time at 20, and hold time at 2
- 1.6.2 Pressure setting at 1. cycle time at 20, and hold time at 3
- Pressure setting at 1. cycle time at 20, and hold time at 4 1.6.3
- Pressure setting at 1. cycle time at 20, and hold time at 5 1.6.4
- 1.6.5 Pressure setting at 3. cycle time at 20, and hold time at 1
- 1.6.6 Pressure setting at 3. cycle time at 20, and hold time at 2
- 1.6.7 Pressure setting at 3. cycle time at 20, and hold time at 3
- 1.6.8 Pressure setting at 3. cycle time at 20, and hold time at 4
- Pressure setting at 3, cycle time at 20, and hold time at 5 1.6.9
- 1.6.10 Pressure setting at 5. cycle time at 20, and hold time at 1
- 1.6.11 Pressure setting at 5. cycle time at 20, and hold time at 2
7
7
SECTION 807.92 b(1) cont
- 1.6.12 Pressure setting at 5, cycle time at 20, and hold time at 3
- 1.6.13 Pressure setting at 5, cycle time at 20, and hold time at 4
- 1.6.14 Pressure setting at 5, cycle time at 20, and hold time at 5
2. Left Foot Wrap
- 2.1 Test pressure at the wrap per operation and maintenance manual page 6-2
- 2.2 Wrap foot wrap around a simulated foot model
- 2.3 Set pulsation settings at pressure setting 1. cycle time at 20, and hold time at 1
- 2.4 From the FOR SERVICE USE ONLY screen press VIEW then press HOME
- 2.5 Under LS write down the pressure reading shown on the screen for five consecutive cycles after the unit has "Ramped-up"
- 2.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14
-
- Left & Right Foot Wrap
- 3.1 Test pressure at the wrap per operation and maintenance manual page 6-2
- 3.2 Wrap foot wraps around simulated foot models
- 3.3 Set pulsation settings at pressure setting 1. cvcle time at 20, and hold time at 1
- 3.4 From the FOR SERVICE USE ONLY screen press VIEW then press HOME
- 3.5 Under RS and LS write down the pressure reading shown on the screen for five consecutive cycles after the unit has "Ramped-up"
- 3.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14
4. Right Arm Wrap
- 4.1 Test pressure at the wrap per operation and maintenance manual page 6-2
- 4.2 Wrap arm wrap around a simulated arm model
- 4.3 Set pulsation settings at pressure setting 1. cycle time at 20, and hold time at 1
- 4.4 From the FOR SERVICE U SE ONLY screen press VIEW then press HOME
- 4.5 Under RS write down the pressure reading shown on the screen for five consecutive cycles after the unit has "Ramped-up"
- 4.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14
8
SECTION 807.92 b(1) cont
5. Left Arm Wrap
- 5.1 Test pressure at the wrap per operation and maintenance manual page 6-2
- 5.2 Wrap arm wrap around a simulated arm model
- 5.3 Set pulsation settings at pressure setting 1, cvcle time at 20, and hold time at 1
- 5.4 From the FOR SERVICE USE ()NLY screen press VIEW then press HOME
- 5.5 Under LS write down the pressure reading shown on the screen for five consecutive cycles after the unit has "Ramped-up"
- 5.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14
-
- Left & Right Arm Wrap
- 6.1 Test pressure at the wrap per operation and maintenance manual page 6-2
- 6.2 Wrap arm wraps around simulated arm models
- 6.3 Set pulsation settings at pressure setting 1. cvcle time at 20, and hold time at I
- 6.4 From the FOR SERVICE USE ONLY screen press VIEW then press HOME
- 6.5 Under RS and LS write down the pressure reading shown on the screen for five consecutive cycles after the unit has "Ramped-up"
- 6.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14
ALARM TESTING PROCEDURE
-
- Low pressure alarm right foot wrap
- 1.1 With scissors cut a 1/8" slit in the bladder area of the wrap
- 1.2 With a good inflatable wrap allow the unit to "ramp-up" at pressure setting 1, cycle time 20, and hold time 1
- 1.3 Replace the good inflatable wrap with the inflatable wrap in step 1.1
- 1.4 If after 5 consecutive cycles the unit alarms then the software passes. Otherwise the software fails
-
- Low pressure alarm left foot wrap repeat steps 1.1 thru 1.5
-
- Low pressure alarm right arm wrap repeat steps 1.1 thru 1.5
-
- Low pressure alarm left arm wrap repeat steps 1 1 thru 1.5
9
-
- High pressure alarm right foot wrap
- 5.1 Kink PVC hose from the unit to the inflatable wrap
- 5.2 If after 5 consecutive cycles the unit alarms then the software passes. Otherwise the software fails
- 5.3 Repeat steps 6.1 and 6.2 for all possible inflatable wrap combinations
-
- Unit malfunction
- 6.1 Disconnect PVC hose from unit
- 6.2 If the unit alarms then the software passes. Otherwise the software fails
SOFTWARE STRESS TEST:
-
- Rapid input
- 1.1 Select any pulsation setting
- 1.2 Allow the unit to "ramp-up"
- 1.3 Now rapidly change pulsation setting. If the unit adjusts to the new pulsation setting then the software passes. Otherwise the software fails
- 1.4 Repeat steps 1.1 thru 1.3 for right and left foot and arm wraps
-
- Operational disrupt
- 2.1 Select any pulsation setting
- 2.2 Allow the unit to "ramp-up"
- 2.3 Now while a wrap is inflated, change the pulsation setting. If on the next cycle the unit operates at the new pulsation setting the software passes. Otherwise the software fails
- 2.4 Repeat steps 2.1 thru 2.3 for right and left foot and arm wraps
10
SECTION 807.92 b(1) cont
RESULTS OF NONCLINICAL TESTING:
152
AVERAGE
128
148
1 36
148 | | 134.4 | | 145.6 | | |42.4 | | |49.6 | | |47.2 || | |48.4
148
152
148
REDOX and Predicate Device (K944567) Software Testing Performed by T. Randolph Test Unit: 61578 Date: 8/2/95 Accessories Wrapped Around High Density Foam Pressure Settings (PS)(1=140 mmHg, 3=160mmHg, 5=180mmHg) Cycle Time (CT) (sec.) Hold Time (HT) (sec.)
| FOOT WRAP | ARM WRAP | |||||||
|---|---|---|---|---|---|---|---|---|
| BILATERAL | BILATERAL | |||||||
| RIGHT | LEFT | RIGHT LEFT | RIGHT | LEFT | RIGHT LEFT | |||
| PS 1, CT 20, HT 1 | 144 | 132 | 144 144 | 152 | 152 | 148 136 | ||
| 140 | 132 | 144 140 | 152 | 144 | 144 144 | |||
| 144 | 132 | 140 140 | 152 | 136 | 148 144 | |||
| 144 | 132 | 140 140 | 152 | 140 | 140 144 | |||
| 144 | 128 | 140 140 | 152 | 140 | 144 136 | |||
| AVERAGE | 143.2 | 131.2 | 141.6 140.8 | 152 | 142.4 | 144.8 140.8 | ||
| PS 1, CT 20, HT 2 | 148 | 124 | 144 140 | 152 | 144 | 148 140 | ||
| 148 | 136 | 144 140 | 156 | 144 | 156 140 | |||
| 148 | 132 | 144 132 | 156 | 148 | 148 140 | |||
| 148 | 132 | 152 140 | 156 | 148 | 148 144 | |||
| 144 | 132 | 144 140 | 152 | 148 | 148 144 | |||
| AVERAGE | 147.2 | 131.2 | 145.6 138.4 | 154.4 | 146.4 | 149.6 141.6 | ||
| PS 1, CT 20, HT 3 | 144 | 132 | 148 132 | 156 | 152 | 148 144 | ||
| 140 | 132 | 144 140 | 148 | 140 | 148 144 | |||
| 144 | 132 | 144 144 | 148 | 144 | 148 144 | |||
| 144 | 132 | 144 132 | 148 | 140 | 148 152 | |||
| 148 | 132 | 144 144 | 148 | 144 | 152 144 | |||
| AVERAGE | 144 | 132 | 144.8 138.4 | 149.6 | 144 | 148.8 145.6 | ||
| PS 1, CT 20, HT 4 | 140 | 140 | 148 144 | 148 | 140 | 144 140 | ||
| 144 | 128 | 148 144 | 156 | 140 | 140 144 | |||
| 148 | 124 | 148 144 | 152 | 140 | 152 140 | |||
| 148 | 128 | 144 144 | 156 | 140 | 148 148 | |||
| 152 | 144 | 144 144 | 148 | 140 | 148 148 | |||
| AVERAGE | 146.4 | 132.8 | 146.4 144 | 152 | 140 | 146.4 144 | ||
| PS 1, CT 20, HT 5 | 144 | 144 | 144 144 | 148 | 152 | 148 140 | ||
| 144 | 144 | 144 144 | 152 | 152 | 152 144 | |||
| 152 | 128 | 144 144 | 144 | 140 | 144 140 | |||
| 148 | 128 | 148 144 | 156 | 140 | 148 148 | |||
| PS 3, CT 20, HT 2 | 167 | 152 | 159 | 159 | 175 | 167 | 167 | 163 |
| 167 | 152 | 163 | 163 | 171 | 167 | 163 | 167 | |
| 167 | 152 | 159 | 163 | 171 | 167 | 167 | 167 | |
| 167 | 152 | 163 | 163 | 171 | 167 | 171 | 167 | |
| 167 | 152 | 159 | 163 | 171 | 159 | 167 | 171 | |
| 167 | 152 | 160.6 | 162.2 | 171.8 | 165.4 | 167 | 167 | |
| PS 3, CT 20, HT 3 | 167 | 152 | 167 | 171 | 171 | 171 | 163 | 167 |
| 167 | 148 | 171 | 163 | 167 | 163 | 163 | 163 | |
| 171 | 148 | 163 | 163 | 167 | 167 | 167 | 167 | |
| 167 | 152 | 159 | 163 | 167 | 171 | 163 | 167 | |
| 167 | 152 | 163 | 163 | 167 | 171 | 171 | 163 | |
| 167.8 | 150.4 | 164.6 | 164.6 | 167.8 | 168.6 | 165.4 | 165.4 | |
| PS 3, CT 20, HT 4 | 167 | 152 | 159 | 163 | 167 | 171 | 163 | 167 |
| 171 | 152 | 163 | 163 | 171 | 171 | 171 | 152 | |
| 171 | 152 | 163 | 163 | 167 | 171 | 167 | 167 | |
| 167 | 152 | 163 | 163 | 167 | 163 | 171 | 152 | |
| 171 | 152 | 163 | 163 | 167 | 163 | 167 | 159 | |
| 169.4 | 152 | 162.2 | 163 | 167.8 | 167.8 | 167.8 | 159.4 | |
| PS 3, CT 20, HT 5 | 163 | 156 | 159 | 167 | 167 | 163 | 167 | 163 |
| 167 | 152 | 163 | 163 | 167 | 163 | 171 | 163 | |
| 167 | 152 | 163 | 163 | 167 | 167 | 171 | 163 | |
| 171 | 152 | 163 | 163 | 171 | 171 | 156 | 152 | |
| 163 | 152 | 163 | 163 | 167 | 156 | 156 | 148 | |
| 166.2 | 152.8 | 162.2 | 163.8 | 167.8 | 164 | 164.2 | 157.8 |
11
148
144
11
| FOOT WRAP | ARM WRAP | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| RIGHT | LEFT | BILATERAL | RIGHT | LEFT | BILATERAL | ||||
| RIGHT | LEFT | RIGHT | LEFT | ||||||
| PS 3, CT 20, HT 1 | 163 | 152 | 163 | 167 | 163 | 167 | 171 | 163 | |
| 156 | 148 | 156 | 156 | 171 | 167 | 171 | 163 | ||
| 163 | 156 | 156 | 159 | 171 | 171 | 171 | 163 | ||
| 159 | 148 | 148 | 159 | 167 | 167 | 167 | 159 | ||
| 159 | 144 | 163 | 159 | 167 | 156 | 171 | 167 | ||
| AVERAGE | 160 | 149.6 | 157.2 | 160 | 167.8 | 165.6 | 170.2 | 163 |
.
12
| AND AND |
|---|
| AVERAGE | 191 | 177.4 | 184.6 | 180.6 | 187 | 182.2 | 187.8 | 179 |
|---|---|---|---|---|---|---|---|---|
| PS 5, CT 20, HT 5 | 191 | 175 | 187 | 183 | 187 | 175 | 187 | 175 |
| 187 | 187 | 187 | 175 | 187 | 179 | 187 | 191 | |
| 191 | 187 | 191 | 187 | 187 | 175 | 191 | 191 | |
| 187 | 183 | 183 | 179 | 187 | 183 | 179 | 191 | |
| 187 | 187 | 191 | 175 | 191 | 183 | 191 | 187 | |
| AVERAGE | 188.6 | 183.8 | 187.8 | 179.8 | 187.8 | 179 | 187 | 187 |
| PS 5, CT 20, HT 4 | 191 | 191 | 183 | 187 | 187 | 179 | 187 | 171 |
|---|---|---|---|---|---|---|---|---|
| 191 | 179 | 183 | 187 | 187 | 183 | 187 | 175 | |
| 191 | 175 | 183 | 175 | 187 | 183 | 187 | 191 | |
| 191 | 167 | 187 | 179 | 187 | 183 | 187 | 171 | |
| 191 | 175 | 187 | 175 | 187 | 183 | 191 | 187 | |
| AVERAGE | 191 | 177.4 | 184.6 | 180.6 | 187 | 182.2 | 187.8 | 179 |
| PS 5, CT 20, HT 3 | 191 | 191 | 191 | 183 | 187 | 179 | 187 | 175 |
|---|---|---|---|---|---|---|---|---|
| 191 | 191 | 183 | 167 | 187 | 183 | 191 | 179 | |
| 187 | 191 | 187 | 183 | 187 | 183 | 191 | 179 | |
| 191 | 179 | 183 | 183 | 187 | 183 | 191 | 179 | |
| 191 | 179 | 183 | 187 | 187 | 179 | 191 | 179 | |
| AVERAGE | 190.2 | 186.2 | 185.4 | 180.6 | 187 | 181.4 | 190.2 | 178.2 |
| PS 5, CT 20, HT 2 | 191 | 191 | 183 | 175 | 187 | 191 | 191 | 179 |
|---|---|---|---|---|---|---|---|---|
| 191 | 187 | 191 | 179 | 187 | 183 | 175 | 179 | |
| 191 | 183 | 183 | 179 | 191 | 191 | 187 | 179 | |
| 191 | 183 | 187 | 179 | 187 | 183 | 191 | 187 | |
| 191 | 179 | 183 | 179 | 187 | 183 | 191 | 187 | |
| AVERAGE | 191 | 184.6 | 185.4 | 178.2 | 187.8 | 186.2 | 187 | 182.2 |
| FOOT WRAP | ARM WRAP | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| RIGHT | LEFT | BILATERAL | |||||||||
| RIGHT LEFT | RIGHT | LEFT | BILATERAL | ||||||||
| RIGHT LEFT | |||||||||||
| PS 5, CT 20, HT 1 | 187 | 179 | 187 175 | 191 | 183 | 179 183 | |||||
| 187 | 183 | 179 175 | 187 | 175 | 187 179 | ||||||
| 187 | 183 | 183 175 | 191 | 187 | 179 187 | ||||||
| 179 | 183 | 179 175 | 187 | 187 | 187 183 | ||||||
| 187 | 187 | 179 167 | 187 | 183 | 179 179 | ||||||
| AVERAGE | 185.4 | 183 | 181.4 173.4 | 188.6 | 183 | 182.2 182.2 |
:
13
ALARM TESTING:
| LOW PRESSURE | HIGH PRESSURE | ||||
|---|---|---|---|---|---|
| YES | NO | YES | NO | ||
| FOOT WRAPS: | |||||
| Right Only | X | X | |||
| Left Only | X | X | |||
| Bilateral: Right | X | X | |||
| Left | X | X | |||
| ARM WRAPS: | |||||
| Right Only | X | X | |||
| Left Only | X | X | |||
| Bilateral: Right | X | X | |||
| Left | X | X | |||
| UNIT MALFUNCTION: | |||||
| Right Hose Removed | X | X | |||
| Left Hose Removed | X | X | |||
| Both Hoses Removed | X | X |
SOFTWARE STRESS TEST:
| RAPID INPUT | OPERATIONAL DISRUPT | ||||
|---|---|---|---|---|---|
| PASS | FAIL | PASS | FAIL | ||
| FOOT WRAPS | |||||
| Right Only | X | X | |||
| Left Only | X | X | |||
| Bilateral: Right | X | X | |||
| Left | X | X | |||
| ARM WRAPS | |||||
| Right Only | X | X | |||
| Left Only | X | X | |||
| Bilateral: Right | X | X | |||
| Left | X | X |
.
14
SECTION 807.92 b(3)
CONCLUSIONS:
The conclusion that follows is based on section 807.92 a(4) "DEVICE DESCRIPTION" pages 1-3, section 807.92 a(5) "INTENDED USE" pages 3-4, section 807.92 a(6) "TECHNOLOGICAL CHARACTERISTICS" pages 4-5, and section 807.92 b(1) "NONCLINICAL TEST AND RESULTS" pages 5-12 of the "510(K) SUMMARY".
The REDOX and the predicate device both employ the same reusable pump unit (controller), including the same electronics and software. The only difference in the REDOX and the predicate device is the inflatable wrap, which is intended for single patient use. The difference is limited to the general shape of the wrap and the location where the wrap is to be used. There has been no change in the function (squeezing the veins) of the wrap. The REDOX wrap simply squeezes the veins in the arm where the predicate wrap squeezes the veins in the foot.
The reusable pump unit of REDOX and the predicate device are the same. Therefore, the structural design, materials, internal components, power supply, electronics, and software are the same. Also, the operation of the unit is the same. This includes the cycle time, hold time, pressure settings, and user interface. The single patient use, inflatable wrap is different; however, the same material and manufacturing processes are used. Therefore. the technological characteristics of REDOX and the predicate device are the same.
Both the REDOX and the predicate device used the same reusable pump unit for the nonclinical testing. Using the same protocol and procedures, there was no statistical difference in the pulsation verification testing. Also, the alarm and software stress testing yielded identical results. Therefore, the nonclinical tests and results were the same.
The conclusions drawn from the nonclinical testing is that the device is safe, effective, and performs as well as the legally marketed predicate device.
CONFIDENTIAL