(100 days)
The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.
Single patient use water seal positive end expiratory pressure device.
The provided text describes a 510(k) premarket notification for the Babi*Plus Bubble PAP Valve, and it primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, many of the requested categories for AI/ML device performance studies are not applicable based on the provided document. The document describes a traditional medical device (a mechanical valve) and its regulatory review, not an AI/ML system.
However, I can extract the information relevant to device performance and substantiation that is present in the text:
Acceptance Criteria and Device Performance (as per the 510(k) submission):
| Acceptance Criteria (Bench Testing Reference) | Reported Device Performance (Babi*Plus Bubble PAP Valve) |
|---|---|
| Meets the requirements set forth in ISO 5356-1:2004 ("Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets"). | Confirmed to meet the requirements of ISO 5356-1:2004. |
| Accuracy at gas flows from 1 to 12 liters per minute. | Bench testing confirmed the accuracy of the device at gas flows from 1 to 12 liters per minute. |
| Substantially equivalent in indications for use, environment of use, patient population, material, and function to identified predicate devices. | Stated as substantially equivalent to pre-1976 and post-1976 predicate devices across these aspects. |
| Performance substantially equivalent to identified predicate devices. | Stated as having substantially equivalent performance to identified predicate devices. |
Study Details (based on information available in the text):
-
Sample size used for the test set and the data provenance:
- The document mentions "Bench testing" but does not specify a sample size for the tests conducted.
- Data provenance is implicitly from internal A Plus Medical testing (bench testing). No country of origin for the data is specified beyond the manufacturer's location. The tests are explicitly "bench testing," meaning they were laboratory-based, not clinical data (retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a physical device undergoing bench testing against engineering standards and functional parameters, not a diagnostic or prognostic AI/ML system requiring expert-established ground truth from clinical cases.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for clinical data adjudication, not bench testing of a mechanical device.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this device type.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device performance described is standalone in the sense that it operates mechanically.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineering standards (ISO 5356-1:2004) and functional measurements (accuracy at specified gas flows).
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that uses training data.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device that uses training data.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string reads 'Kopo317' in a cursive style.
A Plus Medical
Solutions for Respiratory Care
510(k) Summary
Owner:
A Plus Medical 5431 Avenida Encinas, STE G Carlsbad, CA 92008-4411 + 760-930-4025 Tel: + 760-930-0040 Fax:
Owner/Operator Number: 10023166
Official Contact:
Thomas C. Loescher Tel: + 760-930-4025 Fax: + 760-930-0040
Trade Names: Babi*Plus Bubble PAP Valve
Common/Usual Name: PEEP Valve, CPAP Valve, PAP Valve, Bubble CPAP
Classification Name:
Device Name: Attachment, Breathing, Positive End expiratory Pressure Product Code: BYE Regulation: 868.5965 Device Class: 2
Device: Babi*Plus Bubble CPAP Valve
Predicate Devices:
| Number: | Preamendment device |
|---|---|
| Product Name: | Water Seal PEEP Valve |
| Manufacturer: | unknown - believed to be McGaw Laboratories |
| Product Codes: | Unknown |
| Number: | K082092 |
| Product Name: | Disposable PEEP Valve |
| Manufacturer: | GaleMed Corporation |
| Product Codes: | 2421-2425, inclusive and 2461-2481, inclusive |
| Number: | K902062 |
| Product Name: | Disposable PEEP Valve |
| Manufacturer: | Hudson RCI, Temecula, CA (Teleflex Medical, Research Triangle Park, NC) |
| Product Codes: | LIFESAVER® PEEP Valve Models 5383 and 5385 |
5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 図 +740-930-4025 Fax: +760-930-0040 ~ 13 ~
MAY 20 2009
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical Solutions for Respiratory Care. The logo features the letter "a" in a circle on the left, followed by the words "A Plus Medical" in a larger font. Below "A Plus Medical" is the text "Solutions for Respiratory Care" in a smaller font. The logo is black and white.
Device Description:
Single patient use water seal positive end expiratory pressure device.
Indications for Use:
The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.
Contraindications:
Contraindicated in individuals not requiring elevated lung pressure therapy.
Patient Population:
Patient populations from neonate to infant.
Environment of Use:
Hospital
Comparative of Technological Characteristics:
The A Plus Medical Babi*Plus Bubble PAP Valve is substantially equivalent in indications for use, environment of use, patient population, material and function to the identified predicate and to devices that were in the market before 1976 and/or the post 1976 identified predicates. The A Plus Medical Babit PAP Valve and identified predicate device meet the requirements set forth ISO 5356- 1:2004 entitled "Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets". Bench testing confirmed the accuracy of the A Plus Medical BabitPlus Bubble PAP Valve and predicate device at gas flows from 1 to 12 liters per minute.
Conclusion:
The A Plus Medical BabiPlus Bubble PAP Valve is substantially equivalent to the predicate devices that were in the market before 1976 identified predicates. The A Plus Medical BabiPlus Bubble PAP Valve and all identified predicates have substantially equivalent performance. Both devices are made from substantially equivalent material, intended use and patient populations. The A Plus Medical Babi*Plus Bubble PAP Valve is limited to use in acute hospital critical facilities and is contraindicated in individuals not requiring elevated end expiratory pressure, gas flows over 12 LPM, patient transport or non hospital use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Public Health Service
MAY 20 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas C. Loescher, R.R.T. President A Plus Medical 5431 Avenida Encinas, Suite G Carlsbad, California 92008
Re: K090317
Trade/Device Name: Babi*Plus Bubble PAP Valve Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: April 24, 2009 Received: April 28, 2009
Dear Mr. Loescher:
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.
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.
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.
{3}------------------------------------------------
Page 2- Mr. Loescher
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use Statement
(a))
| 510(k) Number: | K090317 |
|---|---|
| Device Name: | Babi*Plus Bubble PAP Valve |
| Indications for Use: | The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions. |
| Prescription Use(Part 21 CFR 801 Subpart D) | X 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. Schult
(Division Sign-Uff) Division of Anesthesiology, General Hospital Intection Control, Dental Devices
510(K) Number: _______________________________________________________________________________________________________________________________________________________________
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).