(77 days)
Not Found
No
The description focuses on the mechanical design and function of headgear for CPAP/bi-level devices and does not mention any computational or algorithmic features.
No
The device is described as an accessory headgear for CPAP or bi-level devices, not a therapeutic device itself. Its function is to optimize fit and patient comfort for therapeutic devices, but it does not provide therapy.
No
Explanation: The device is described as an accessory headgear for CPAP or bi-level devices. Its function is to provide fit and comfort for standard patient interfaces, not to diagnose a medical condition.
No
The device description clearly states it is a physical headgear accessory for CPAP/bi-level devices, not software.
Based on the provided information, the PAP-Cap™ headgear is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- PAP-Cap™ Function: The PAP-Cap™ headgear is described as an accessory for CPAP/bi-level devices. Its function is to secure a patient interface (mask) to the patient's head for respiratory therapy. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it's for patients using CPAP or bi-level devices and is an accessory to those devices.
- Device Description: The description focuses on its physical design and how it attaches to masks.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or any other activities associated with IVD devices.
Therefore, the PAP-Cap™ headgear falls under the category of a medical device, but specifically as an accessory for respiratory therapy devices, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
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.
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
hospitals, institutions, sleep labs, and for home environments.
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)
Not Found
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
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
Page 1 of 2
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)
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
Pur-Sleep
PAP-Cap™ headgear | Predicate
K042294
Suiter Slumbergear™ headgear |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Slumbergear™ headgear is an accessory to
a non-continuous ventilator (respirator),
intended for adult patients prescribed
continuous positive airway pressure
(CPAP) and bi-level therapy in hospital,
clinics, and / or home environments. The
headgear is reusable and for single use. |
| Environment of use | Hospital, institutions, sleep labs
and home use | Hospital, clinics and home use |
| Patient Population | Same patient population as the
equipment to which it is attached | Adults |
| Prescriptive | Yes | Yes |
| Patient interface types | Full face mask
Nasal mask
Nasal pillows
Cannulas | Mask
Nasal pillows
Cannulas |
| Design features | One-piece
Integrated chinstrap
Velcro® attachment means
Emergency exit method | One-piece
Integrated chinstrap
Velcro® attachment means
Emergency exit method |
| Latex Free | Yes | Yes |
| Single patient, multi-use | Yes | Yes |
| Cleaning method | Standard washer or
Hand 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.
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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.
3
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
4
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: