PAP-CAP

K100343 · Pur-Sleep, Inc. · BZD · Apr 23, 2010 · Anesthesiology

Device Facts

• Record ID: K100343
• Device Name: PAP-CAP
• Applicant: Pur-Sleep, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2

Indications for Use

PAP-Cap™ headgear is an accessory intended for patients using CPAP or bi-level devices in hospitals, institutions, sleep labs, and /or home environments. The headgear is single patient, multi-use.

Device Story

PAP-Cap™ is a one-piece headgear accessory for CPAP or bi-level therapy devices; features integrated, detachable chin strap; utilizes Velcro® attachment for secure fit; includes emergency exit mechanism. Designed for use in hospitals, sleep labs, and home environments by patients requiring respiratory support. Device stabilizes patient interfaces (masks, pillows, cannulas) to optimize fit and comfort. Single-patient, multi-use design; latex-free; washable. No electronic components or software.

Clinical Evidence

No clinical data. Substantial equivalence is based on descriptive comparisons of design, materials, and intended use.

Technological Characteristics

One-piece headgear with integrated chin strap; Velcro® attachment; latex-free materials; manual cleaning (standard washer or hand wash). No energy source, software, or electronic components.

Indications for Use

Indicated for patients requiring CPAP or bi-level therapy in hospitals, institutions, sleep labs, or home environments. Compatible with full face masks, nasal masks, nasal pillows, and cannulas.

Regulatory Classification

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.

Predicate Devices

• Suiter - Slumbergear™ headgear (K042294)

Submission Summary (Full Text)

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Premarket Notification 510(k) Section 5 - 510(k) Summary - Pur-Sleep PAP-Cap™

Pur-Sleep, Inc.
PO Box 95245
South Jordan, UT 84095

| | 510(k) Summary<br>Page 1 of 2<br>3-Feb-10 | KI00343 |
|----------------------------|---------------------------------------------------------|--------------|
| | Tel (O) 801-916-2864 | APR 2 3 2010 |
| Official Contact: | Bret Randall - Owner | |
| Proprietary or Trade Name: | PAP-Cap™ | |
| Common/Usual Name: | Headgear | |
| Classification Name/Code: | BZD - ventilator, non-continuous (IPPB)<br>CFR 868.5905 | |
| Device: | PAP-Cap™ | |
| Predicate Devices: | Suiter - Slumbergear™ headgear - K042294 | |

#### Device Description:

The Pur-Sleep PAP-Cap™ is a simple alternative headgear (with an integrated but fully detachable chin strap) designed to be used with standard patient interfaces, i.e., full face mask, nasal mask and nasal pillow and cannula devices. It is designed to be adjusted to optimize fit and patient comfort. It is adaptable to many models of CPAP mask styles.

#### Indications for Use:

PAP-Cap™ headgear is an accessory intended for patients using CPAP or bi-level devices in hospitals, institutions, sleep labs, and for home environments. The headgear is single patient, multi-use. : ..

#### Environment of Use: ·

Hospital, institutions, sleep labs, and home environments

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## Premarket Notification 510(k) Section 5 - 510(k) Summary

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# Pur-Sleep PAP-Cap™

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### 510(k) Summary Page 2 of 2 ・ 3-Feb-10

### Summary of substantial equivalence

| | Proposed<br>Pur-Sleep<br>PAP-Cap™ headgear | Predicate<br>K042294<br>Suiter Slumbergear™ headgear |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | PAP-Cap™ headgear is an<br>accessory intended for patients<br>using CPAP or bi-level devices in<br>hospitals, institutions, sleep labs,<br>and /or home environments. The<br>headgear is single patient, multi-<br>use. | Slumbergear™ headgear is an accessory to<br>a non-continuous ventilator (respirator),<br>intended for adult patients prescribed<br>continuous positive airway pressure<br>(CPAP) and bi-level therapy in hospital,<br>clinics, and / or home environments. The<br>headgear is reusable and for single use. |
| Environment of use | Hospital, institutions, sleep labs<br>and home use | Hospital, clinics and home use |
| Patient Population | Same patient population as the<br>equipment to which it is attached | Adults |
| Prescriptive | Yes | Yes |
| Patient interface types | Full face mask<br>Nasal mask<br>Nasal pillows<br>Cannulas | Mask<br>Nasal pillows<br>Cannulas |
| Design features | One-piece<br>Integrated chinstrap<br>Velcro® attachment means<br>Emergency exit method | One-piece<br>Integrated chinstrap<br>Velcro® attachment means<br>Emergency exit method |
| Latex Free | Yes | Yes |
| Single patient, multi-use | Yes | Yes |
| Cleaning method | Standard washer or<br>Hand wash warm water and soap,<br>air dry | Hand wash warm water and soap, air dry |

It is our view that there are no differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

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11.11.2017

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pur-Sleep, Incorporated C/O Mr. Paul Dryden President Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

APR 2 3 2010

Re: K100343

Trade/Device Name: РАР-САРТМ Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 3, 2010 Received: February 5, 2010

Dear Mr. Paul Dryden:

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.

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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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and General Hospital, Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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## Indications for Use Statement

Page 1 of 1

510(k) Number:

K je e 343 (To be assigned)

PAP-Cap™ Device Name:

Indications for Use:

PAP-Cap™ headgear is an accessory intended for patients using CPAP or bi-level devices in hospitals, institutions, sleep labs, and /or home environments. The headgear is single patient, multi-use.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K 100 343 510(k) Number: