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 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.

AI/ML Overview

The Pur-Sleep PAP-Cap™ is a headgear device designed to be used with CPAP or bi-level devices. The provided documents focus on establishing substantial equivalence to a predicate device (Suiter - Slumbergear™ headgear - K042294) rather than presenting a study demonstrating the device meets explicit acceptance criteria through performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided documents, there are no explicit quantitative acceptance criteria or performance metrics reported for the Pur-Sleep PAP-Cap™. The submission relies on demonstrating substantial equivalence to a predicate device. Therefore, the "reported device performance" is essentially that it is substantially equivalent to the predicate across various features.

Feature	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Pur-Sleep PAP-Cap™)
Indications for Use	Accessory for CPAP/bi-level, adult patients, in hospital, clinics, home environments, reusable, single use.	Accessory for CPAP/bi-level, patients (same as attached equipment), in hospitals, institutions, sleep labs, home environments, single patient, multi-use. (Minor wording differences, overall equivalent intent)*
Environment of Use	Hospital, clinics, and home use.	Hospital, institutions, sleep labs, and home use. (Minor wording differences, overall equivalent intent)*
Patient Population	Adults.	Same patient population as the equipment to which it is attached. (Consistent with predicate's adult focus for CPAP/bi-level)*
Prescriptive	Yes.	Yes.
Patient Interface Types	Mask, Nasal pillows, Cannulas.	Full face mask, Nasal mask, Nasal pillows, Cannulas. (Broader than predicate - implies sufficient compatibility)*
Design Features	One-piece, integrated chinstrap, Velcro® attachment, emergency exit method.	One-piece, integrated chinstrap, Velcro® attachment, emergency exit method.
Latex Free	Yes.	Yes.
Single patient, multi-use	Yes.	Yes.
Cleaning Method	Hand wash warm water and soap, air dry.	Standard washer or hand wash warm water and soap, air dry. (Broader than predicate - implies acceptable cleaning methods)*

Note: The differences in wording for Indications for Use, Environment of Use, Patient Population, and Cleaning Method are considered minor by the FDA as they did not impact the substantial equivalence determination for safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance:

No specific test set or clinical study data is presented in these documents. The submission is a 510(k) premarket notification, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical trials for performance. Therefore, information on sample size or data provenance is not applicable in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as no specific test set or clinical study requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set:

Not applicable, as no specific test set or clinical study is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done or reported in these documents. This type of study focuses on the diagnostic performance of human readers with and without AI assistance, which is not relevant for a simple headgear device being cleared via substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The PAP-Cap™ is a mechanical accessory (headgear), not an algorithm or software-based device. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used:

Not applicable. The basis for clearance is substantial equivalence to a predicate device based on comparison of intended use, technological characteristics, and safety/effectiveness, not on a ground truth derived from expert consensus, pathology, or outcomes data for performance evaluation.

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device (headgear), there is no "training set" in the context of machine learning or algorithms. The design and validation would typically involve engineering tests, material biocompatibility, and user evaluations, but these are not explicitly detailed as "training sets" in the provided summary.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the reasons stated in point 8.

Summary

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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) SummaryPage 1 of 23-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)CFR 868.5905
Device:	PAP-Cap™
Predicate Devices:	Suiter - Slumbergear™ headgear - K042294

Device Description:

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™

510(k) Summary Page 2 of 2 ・ 3-Feb-10

Summary of substantial equivalence

	ProposedPur-SleepPAP-Cap™ headgear	PredicateK042294Suiter Slumbergear™ headgear
Indications for Use	PAP-Cap™ headgear is anaccessory intended for patientsusing CPAP or bi-level devices inhospitals, institutions, sleep labs,and /or home environments. Theheadgear is single patient, multi-use.	Slumbergear™ headgear is an accessory toa non-continuous ventilator (respirator),intended for adult patients prescribedcontinuous positive airway pressure(CPAP) and bi-level therapy in hospital,clinics, and / or home environments. Theheadgear is reusable and for single use.
Environment of use	Hospital, institutions, sleep labsand home use	Hospital, clinics and home use
Patient Population	Same patient population as theequipment to which it is attached	Adults
Prescriptive	Yes	Yes
Patient interface types	Full face maskNasal maskNasal pillowsCannulas	MaskNasal pillowsCannulas
Design features	One-pieceIntegrated chinstrapVelcro® attachment meansEmergency exit method	One-pieceIntegrated chinstrapVelcro® attachment meansEmergency exit method
Latex Free	Yes	Yes
Single patient, multi-use	Yes	Yes
Cleaning method	Standard washer orHand wash warm water and soap,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.

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 (800) 638-2041 or (301) 796-7100 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:

Regulation Number and Section

§ 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).