(181 days)
Not Found
No
The device description and performance studies focus on the physical components and material properties of a respiratory mask, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a mask that channels airflow from a positive airway pressure device; it does not directly provide therapy but is an interface for a therapeutic system.
No
This device is a mask used to channel airflow from a positive airway pressure device for therapeutic purposes, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical mask interface and headgear, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "channels airflow non-invasively to a patient from a positive airway pressure device." This describes a device used for respiratory support, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical components of a respiratory mask and how it delivers air. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring substances in these specimens.
- Providing diagnostic information.
The device is a medical device used for delivering positive airway pressure, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve "Mask is: 1. to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed. 2. intended for single-patient re-use in the home, hospital, and sub-acute environment.
The iVolve® Mask channels airflow non-invasively to a partive arway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve® Mask is: 1. to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed. 2. intended for single-patient re-use in the home, hospital, and sub-acute environment.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The iVolve® N2 and Nasal Masks are respiratory nasal mask interfaces that directs airflow from a positive pressure device to the patient's nose. The iVolve® Full-Face Mask is a mask interface that directs air flow from a positive pressure device to the patient's nose or mouth. The iVolve® Mask Series is held in place with adjustable headgear that straps the mask to the face. The iVolve® is safe when used under the conditions and purposes intended as indicated the labeling provided with the product. The iVolve® is a prescription device supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose, nose or mouth
Indicated Patient Age Range
Adult patients (>66lb/30 kg)
Intended User / Care Setting
single-patient re-use in the home, hospital, and sub-acute 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The materials used in the iVolve series are identical to those used in the predicate Willow mask and have undergone and passed biocompatibility testing in accordance with ISO 10993: cytotoxicity, animal skin irritation, implantation, genotoxicity, and Kligman maximization. Home Cleaning Validation Testing confirms that the iVolve mask series can withstand 200 cycles of cleaning and assessment for degradation of materials, including simulated use. Both the proposed devices and the predicate devices have similar performance characteristics as shown in the substantial equivalence table. Performance bench testing of the proposed iVolve Mask Series did not raise any new questions of safety and efficacy. The iVolve was performance bench tested against the ResMed Mirage Activa (K030798) and the ResMed Mirage Quattro (K113127). As the tables below show, in terms of performance characteristics (i.e. passive exhalation port flow, resistance to flow, and dead space), the two devices are substantially equivalent.
iVolve Nasal Mask:
Flow/Pressure Curve: M* size, 3 samples. Objective: a) to meet intended product specifications; b) to compare to range of predicate ±15%. Result/Conclusion: within limits/pass.
Pressure Drop/Resistance: M* size, 3 samples. Objective: a) to meet intended product specifications; b) to compare to range of predicate ±15%. Result/Conclusion: within limits/pass.
Dead Space: s,m,l sizes, 3 samples. Objective: a) to meet intended product specifications; b) to compare to range of predicate ±15%. Result/Conclusion: within limits/pass.
iVolve N2 Nasal Mask:
Flow/Pressure Curve: M* size, 3 samples. Objective: a) to meet intended product specifications; b) to compare to range of predicate +15%. Result/Conclusion: within limits/pass.
Pressure Drop/Resistance: M* size, 3 samples. Objective: a) to meet intended product specifications; b) to compare to range of predicate +15%. Result/Conclusion: within limits/pass.
Dead Space: s,m,l sizes, 3 samples. Objective: a) to meet intended product specifications; b) to compare to range of predicate +15%. Result/Conclusion: within limits/pass.
iVolve Full-Face Mask:
Flow/Pressure Curve: M* size, 3 samples. Objective: a) to meet intended product specifications; b) to compare to range of predicate ±15%. Result/Conclusion: within limits/pass.
Pressure Drop/Resistance: M* size, 3 samples. Objective: a) to meet intended product specifications; b) to compare to range of predicate + I 2 %. Result/Conclusion: within limits/pass.
Dead Space: s,m,l sizes, 3 samples. Objective: a) to meet intended product specifications; b) to compare to range of predicate +15%. Result/Conclusion: within limits/pass.
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.
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
KI31901
DEC 2 3 2013
iVolve® Nasal Mask Series
Section 6: 510(k) Summary
Section 6: 510(k) SUMMARY
[As required by 21 CFR §807.92(c)]
Date Prepared:
Official Contact:
Alex Lucio
·June 12, 2013
Vice President
3B Medical, Inc.
21301 Highway 27N
Lake Wales, FL 33859
Tel: (863) 226-6284
Email: alucio@3Bproducts.com
Device Trade Name:
・
iVolve® Nasal Mask iVolve® Full Face Mask
iVolve® N2
| Device Common Name: | Nasal Mask, Full Face Mask |
|---|---|
| Classification Name: | Vented Nasal Mask |
| Classification: | 21 CFR §868.5905, 73 BZD (CLASS II) |
| Product Code: | BZD |
| Predicate Devices: | Manufacturer: | Resmed |
|---|---|---|
| Trade Name: | Mirage Activa LT Nasal Mask | |
| 510(k) Number: | K030798 |
1
| Manufacturer: | Resmed |
|---|---|
| Trade Name: | Mirage Quattro Full Face Mask |
| 510(k) Number: | K113127 |
| Manufacturer: | BMC |
| Trade Name: | Willow Nasal Mask |
| 510(k) Number: | K112271 |
Device Description:
The iVolve® N2 and Nasal Masks are respiratory nasal mask interfaces that directs airflow from a positive pressure device to the patient's nose. The iVolve® Full-Face Mask is a mask interface that directs air flow from a positive pressure device to the patient's nose or mouth. The iVolve® Mask Series is held in place with adjustable headgear that straps the mask to the face.
The iVolve® is safe when used under the conditions and purposes intended as indicated the labeling provided with the product.
The iVolve® is a prescription device supplied non-sterile.
Intended Use:
The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve "Mask is:
to be used by adult patients (>66lb/30 kg) for whom 1. positive airway pressure has been prescribed.
intended for single-patient re-use in the home, hospital, 2. and sub-acute environment.
2
iVolve® Nasal Mask Series
Contraindications: None
Clinical Test: None
Technological Characteristics Comparison:
A comparative table of the iVolve alongside the three identified predicate devices indicates that the iVolve Mask Series is substantially equivalent with the other three with respect to the form, performance, materials, structures and the ventilation characteristics.
The iVolve mask series, including the iVolve Nasal, iVolve Full Face, and iVolve N2, are identical to the identified predicate Willow device in material composition (i.e. silicone, molded plastic, and nylon fabric). Both the proposed devices and the predicate devices connect to a conventional air delivery hose between the mask and the positive airway pressure source via standard conical connectors (ISO 5356-1-2004).
Both the proposed devices (the iVolve Mask Series) and the predicate devices have similar technical performance characteristics, including pressure-flow characteristics and flow impedance.
| Manufacture | BMC | RESmed | RESmed | BMC | With Headgear | Yes | Yes | Yes | Yes |
|---|---|---|---|---|---|---|---|---|---|
| Model | iVolve® Nasal | ||||||||
| Mask | Mirage™ Activa LT | ||||||||
| Nasal Mask | |||||||||
| (K030798) | Mirage™ Quattro | ||||||||
| Full Face Mask | |||||||||
| (K113127) | Willow Nasal | ||||||||
| Mask | |||||||||
| (K112271) | With Clips | Yes | Yes | Yes | Yes | ||||
| Picture | Image: iVolve Nasal Mask | Image: Mirage Activa LT Nasal Mask | Image: Mirage Quattro Full Face Mask | Image: Willow Nasal Mask | Multi Size | Yes | Yes | Yes | Yes |
| Intended use | Dead Space – | ||||||||
| (empty volume of the | |||||||||
| mask to the end of | |||||||||
| the swivel) | Nasal Mask | ||||||||
| S: 123.6ml | |||||||||
| M: 134ml | |||||||||
| L: 145 ml | |||||||||
| Full-Face Mask | |||||||||
| S: 220ml | |||||||||
| M: 232ml | |||||||||
| L: 246ml | |||||||||
| N2 Mask | |||||||||
| S:123.6ml | |||||||||
| M: 129ml | |||||||||
| L: 134.1ml | S: 123.3ml | ||||||||
| M: 134.1ml | |||||||||
| L: 145.2ml | S: 217ml | ||||||||
| M: 228ml | |||||||||
| L: 243ml | |||||||||
| The iVolve® | |||||||||
| channels airflow | |||||||||
| noninvasively to | |||||||||
| a patient from a | |||||||||
| positive airway | |||||||||
| pressure device | |||||||||
| such as a | |||||||||
| continuous | |||||||||
| positive airway | |||||||||
| pressure | |||||||||
| (CPAP) or Bi- | |||||||||
| level system. | |||||||||
| The iVolve® is: | |||||||||
| To be used | |||||||||
| by adult | |||||||||
| patients (>30 | |||||||||
| kg) for whom | |||||||||
| positive | |||||||||
| airway | |||||||||
| pressure has | |||||||||
| been | |||||||||
| prescribed. Intended for | |||||||||
| single-patient | |||||||||
| re-use in the | |||||||||
| home | |||||||||
| environment. Intended for | |||||||||
| prescription | |||||||||
| use only. | Mirage | ||||||||
| Activa™ mask | |||||||||
| is an | |||||||||
| accessory to a | |||||||||
| non- | |||||||||
| continuous | |||||||||
| ventilator | |||||||||
| (respirator) | |||||||||
| intended for | |||||||||
| single-patient | |||||||||
| use for adult | |||||||||
| patients | |||||||||
| prescribed | |||||||||
| continuous | |||||||||
| positive | |||||||||
| airway | |||||||||
| pressure | |||||||||
| (CPAP) and bi- | |||||||||
| level therapy | |||||||||
| in hospital, | |||||||||
| clinic, and | |||||||||
| home | |||||||||
| environments. | The Mirage™ | ||||||||
| Quattro Full Face | |||||||||
| Mask channels | |||||||||
| airflow | |||||||||
| noninvasively to a | |||||||||
| patient from a | |||||||||
| positive airway | |||||||||
| pressure device | |||||||||
| such as a | |||||||||
| continuous | |||||||||
| positive airway | |||||||||
| pressure (CPAP) or | |||||||||
| bi-level system. | |||||||||
| The Mirage™ | |||||||||
| Quattro is to be | |||||||||
| used by adult | |||||||||
| patients (>66lb/ |
30kg) for whom
positive airway
pressure has been
prescribed. The
Mirage™ Quattro is
intended for single
patient re-use in
the home
environment and/or
hospital/
institutional
environment. | The Willow™
channels
airflow
noninvasively
to a patient
from a
positive
airway
pressure
(PAP) device
or a bilevel
system. The
WillowTM is:
(1) to be used
by adult
patients (>
66lb / 30 kg)
for the
treatment of
sleep
disordered
breathing,
such as
obstructive
sleep apnea
(OSA), for
whom
positive
airway
pressure has
been
prescribed.
(2) to be used
for single-
patient reuse
in the home
environment. | Chemical Characteristics | | | | |
| Construction | | | | | Cushion | Silicone | Silicone | Silicone | Silicone |
| Nasal | Yes | Yes | Yes | Nasal pillows | Headgear | stretch nylon | stretch nylon | stretch nylon | stretch nylon |
| Dual-wall Cushion | Yes | Yes | Yes | | Specification | | | | |
| Adjustable Forehead
Support | Yes | Yes | Yes | | Therapy Pressure | 4-30cmH20 | 4-20 cmH2O | 4-20 cmH2O | 4-20 cmH2O |
| connector | 22mm | 22mm | 22mm | 22mm | | | | | |
| Resistance/Pressure
Drop
iVolve Nasal Mask | 0.2 cmH2O at
50L/min
0.7 cmH2O at
100L/min | 0.4 cmH2O at
50L/min
0.9 cmH2O at
100L/min | | 1.0 cmH2O at
50L/min
3.1 cmH2O at
100L/min | | | | | |
| iVolve Full Face
Mask | 0.1 cm H2O at
50L/min
0.5 cm H2O at
100L/min | 0.4 cm H2O at
50ml/min | 0.2 cmH2O at
50L/min
0.4 cmH2O at
100L/min | | | | | | |
SE Table
3
3
:
:
4
:
4
5
| iVolve N2 | 50L/min
0.5 cm H2O at
100L/min | 0.9 cm H2O at
100ml/min | | |
|----------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Operating and Storage Conditions | | | | |
| Operating | +5 to +40°C
15% to 93%
relative
humidity, non-
condensing | +5 to +40°C
15% to 95%
relative
humidity, non-
condensing | -41 to 104°F(+5 to
+40°C)
15% to 95% relative
humidity, non-
condensing | +5°C to +40°C
10%-93 %
relative
humidity non-
condensing |
| Storage | -20 to +55°C
10% to 93%
relative
humidity, non-
condensing | -20 to +60°C
up to 95%
relative
humidity, non-
condensing | -4 to 140°F(-20 to
+60°C)
15% to 95% relative
humidity, non-
condensing | -20°C to +
55°C
10%-93 %
relative
humidity non-
condensing |
Non-Clinical Performance Data:
The materials used in the iVolve series are identical to those used in the predicate Willow mask and have undergone and passed biocompatibility testing in accordance with ISO 10993: cytotoxicity, animal skin irritation, implantation, genotoxicity, and Kligman maximization.
Home Cleaning Validation Testing confirms that the iVolve mask series can withstand 200 cycles of cleaning and assessment for degradation of materials, including simulated use.
Both the proposed devices and the predicate devices have similar performance characteristics as shown in the substantial equivalence table. Performance bench testing of the proposed iVolve Mask Series did not raise any new questions of safety
6
and efficacy.
The iVolve was performance bench tested against the ResMed Mirage Activa (K030798) and the ResMed Mirage Quattro (K113127). As the tables below show, in terms of performance characteristics (i.e. passive exhalation port flow, resistance to flow, and dead space), the two devices are substantially equivalent.
| iVolve Nasal Mask | |||||
|---|---|---|---|---|---|
| Name of Test | Reason for Test | Size Tested | No. Samples Tested | Objective | Result/Conclusion |
| Flow/Pressure | |||||
| Curve | to determine the flow/pressure curve at pressures 4, 8, 12, 16, 20, 25, 30 cmH2O | M* | 3 | a) to meet intended product specifications; b) to compare to range of predicate ±15% | within limits/pass |
| Pressure | |||||
| Drop/Resistance | to determine the pressure drop/resistance to flow at 50, 100L/min. | M* | 3 | a) to meet intended product specifications; b) to compare to range of predicate ±15% | within limits/pass |
| Dead Space | to determine the dead space for each size | s,m,l | 3 | a) to meet intended product specifications; b) to compare to range of predicate ±15% | within limits/pass |
| iVolve N2 Nasal Mask
| A----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| And And Commend Comments of Children Comments of Children |
7
iVolve® Nasal Mask Series
| Name of Test | Reason for
Test | Size
Tested | No.
Samples
Tested | Objective | Result/Conclusion |
|-----------------------------|--------------------------------------------------------------------------------|----------------|--------------------------|-----------------------------------------------------------------------------------------------------------|--------------------|
| Flow/Pressure
Curve | to determine
the pressure
drop/resistance
to flow at 50,
100L/min. | M* | 3 | a) to meet
intended
product
specifications;
b) to compare
to range of
predicate
+15% | within limits/pass |
| Pressure
Drop/Resistance | to determine
the pressure
drop/resistance
to flow at 50,
100L/min. | M* | 3 | a) to meet
intended
product
specifications;
b) to compare
to range of
predicate
+15% | within limits/pass |
| Dead Space | to determine
the dead space
for each size | s,m,l | 3 | a) to meet
intended
product
specifications;
b) to compare
to range of
predicate
+15% | within limits/pass |
| iVolve Full-Face Mask | |||||
|---|---|---|---|---|---|
| Name of Test | Reason for | ||||
| Test | Size | ||||
| Tested | No. | ||||
| Samples | |||||
| Tested | Objective | Result/Conclusion | |||
| Flow/Pressure | |||||
| Curve | to determine | ||||
| the | |||||
| flow/pressure | |||||
| curve at | |||||
| pressures 4, 8, | |||||
| 12, 16, 20, 25, | |||||
| 30 cmH20 | M* | 3 | a) to meet | ||
| intended | |||||
| product | |||||
| specifications; | |||||
| b) to compare | |||||
| to range of | |||||
| predicate | |||||
| ±15% | within limits/pass |
8
.
| Pressure
Drop/Resistance | to determine
the pressure
drop/resistance
to flow at 50,
100L/min. | M* | 3 | a) to meet
intended
product
specifications;
b) to compare
to range of
predicate
- I 2 % | within limits/pass |
|-----------------------------|--------------------------------------------------------------------------------|-------|---|--------------------------------------------------------------------------------------------------------------|--------------------|
| Dead Space | to determine
the dead space
for each size | s,m,l | 3 | a) to meet
intended
product
specifications;
b) to compare
to range of
predicate
+15% | within limits/pass |
.
9
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2013
3B Medical, Incorporated Mr. Alex Lucio Vice President 21301 Highway 27N Lake Wales, FL 33859
Re: K131901
Trade/Device Name: iVolve Nasal Mask, iVolve Full Face Mask, iVolve N2 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 15, 2013 Received: November 19, 2013
Dear Mr. Lucio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that 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 may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
10
Page 2 - Ms. Lucio
· · · 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Sincerely yours.
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Image /page/10/Picture/7 description: The image contains a combination of text and graphic elements. The text includes "Tejashri Purohit-Sheth, M.D.", "Clinical Deputy Director", and "DAGRID". There is also a complex graphic element that appears to be a stylized signature or logo, with swirling lines and abstract shapes. The word "FOR" is also present in the image.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known) K131901
Device Name iVolve Mask Series
Indications for Use (Describe)
The iVolve® Mask channels airflow non-invasively to a partive arway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.
The iVolve® Mask is:
-
- to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed.
- intended for single-patient re-use in the home, hospital, and sub-acute environment
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/11/Picture/15 description: The image contains text that appears to be a timestamp and a name. The name is "Anya C. Harry -S". The timestamp is "2013.12.23 11:46:31 -05'00'". The text is black and the background is white.
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
12
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."