(87 days)
Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.
Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.
The document provided outlines the A Plus Medical Babi.Plus™ Neonatal Resuscitation Bag and its substantial equivalence to a predicate device. The primary study presented relates to comparative technological characteristics rather than a clinical study involving human patients or complex AI algorithms.
Here's a breakdown of the requested information based on the provided text, noting where information is not applicable or not present:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the ISO 10651-4:2002 standard ("Lung ventilators - Part 4: Particular requirements for opered resuscitators") and the predicate device's performance. The "Babi.Plus™" column shows the reported device performance.
| Item | Acceptance Criteria (Implied by Predicate/ISO) | Reported Device Performance (Babi.Plus™) |
|---|---|---|
| Patient Connector: | 15 mm I.D. / 22 mm O.D. (Predicate) | 15 mm I.D. |
| Face Mask: | Option offered, 15 mm O.D. (Predicate) | Option offered, 15 mm O.D. |
| Pressure Gauge Connector: | None (Predicate) | 4.0 mm O.D. tapered |
| Supplemental oxygen delivery: | (Predicate values given) | VT-20 mls, Rate – 60 BPM:@ 2 LPM – 91%, @ 10 LPM – 99+%VT-20 mls, Rate – 120 BPM:@ 2 LPM – 91%, @ 10 LPM – 99+ %VT-50 mls, Rate – 30 BPM:@ 2 LPM – 75%, @ 10 LPM – 99+%VT-50 mls, Rate – 60 BPM:@ 2 LPM – 66%, @ 10 LPM – 99+% |
| Expiratory resistance: | < 2.8 cm H2O @ 5 LPM (Predicate) | < 1.7 cm H2O @ 5 LPM |
| Inspiratory resistance: | < 2.8 cm H2O @ 5 LPM (Predicate) | < 1.3 cm H2O @ 5 LPM |
| Patient Valve malfunction: | < 6.0 cm H2O @ 30 LPM (Predicate) | < 6.0 cm H2O @ 30 LPM |
| Dead space: | 6.8 mls (Predicate) | 6.35 mls |
| Minimum / Maximum Volume: | 20 mls / 150 mls (Predicate) | 20 mls / 50 mls |
| Body mass range: | ≤ 10.0 Kg (Predicate) | ≤3.3 Kg |
| Pressure limitation: | 40 cm H2O ± 5.0 cm H2O with over-ride, unlimited pressure (Predicate) | 25 cm H2O ± 3.0 cm H2O with 40 cmH2O ± 5.0 cm H2O over-ride |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a pre-market notification (510(k)) based on substantial equivalence, primarily through a comparison of technical characteristics to a known predicate device and conformity to an international standard (ISO 10651-4:2002).
- Test Set Sample Size: Not applicable. The "study" presented here is a summary of comparative technical specifications, not a clinical trial or performance evaluation using a "test set" in the context of AI/diagnostic device validation. The performance values listed (e.g., oxygen delivery, resistance) would have been determined through engineering tests on a sample of the device, but the sample size for these specific tests is not provided.
- Data Provenance: Not applicable in the sense of clinical data. The performance data is generated through laboratory testing of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study that involves expert ground truth for image interpretation or diagnosis. The "ground truth" for the technical specifications is based on established engineering principles, metrology, and compliance with the ISO standard.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process described or implied for the generation of these technical performance metrics.
5. 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-enabled diagnostic device, nor is it a multi-reader study. It is a manual resuscitation bag.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (manual resuscitation bag), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance characteristics (e.g., flow rates, volumes, resistances) is established through physical measurement and testing against the requirements of ISO 10651-4:2002 and comparison with the specifications of the predicate device. It is an engineering "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" or corresponding ground truth establishment described.
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Image /page/0/Picture/0 description: The image shows the logo for A Plus Medical. The logo consists of the letter "a" in a circle, followed by the words "A Plus Medical" in a bold font. Below the words "A Plus Medical" is the phrase "Solutions for Respiratory Care" in a smaller font. The logo is black and white.
K 112852 રું... 510(k) Summary
December 12, 2011 Date:
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 + 760-930-4025 Tel: + 760-930-0040 Fax:
Trade Names: Bobs. Plus" Neonatal Resuscitation Bag Babs. Plus" N Bag
Common/Usual Name:
Manual Resuscitation Bag
Classification Name:
Device Name: Ventilator, Emergency, Manual (Resuscitator
Product Code: BTM
Regulation: CFR 868.5915
II
Device Class:
Device: Babs. Plus Neonatal Resuscitation Bag
Predicate Devices:
| Number: | K082092 |
|---|---|
| Product Name: | Dispo - Manual Resuscitation Bag |
| Manufacturer: | GaleMed Corporation |
| Product Codes: | 2328 |
Device Description:
Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.
Indications for Use:
Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.
5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 2 . +740-930-4025 Fax: +760-930-0040 ~ 13~~
JAN 1 3 2012
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Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical. The logo consists of the letter "a" inside of a circle on the left, followed by the words "A Plus Medical" in bold font. Below "A Plus Medical" are the words "Solutions for Respiratory Care" in a smaller font.
Contraindications:
Body mass greater than 3.3 Kg.
Patient Population:
Patient populations of neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg.
Environment of Use:
Hospital, transport, emergency and post hospital care environments
Comparative of Technological Characteristics:
Babs. Plus" and predicate products conform to requirements set forth in ISO 10651-4:2002 entitled "Lung ventilators -Part 4: Particular requirements for opered resuscitators". A summary of critical performance attributes include:
| Item | Babi.Plus™ | Predicate |
|---|---|---|
| Patient Connector: | 15 mm I.D. | 15 mm I.D. / 22 mm O.D. |
| Face Mask: | Option offered, 15 mm O.D. | Option offered, 15 mm O.D. |
| Pressure Gauge Connector: | 4.0 mm O.D. tapered | None |
| Supplemental oxygen delivery: | VT-20 mls, Rate – 60 BPM:@ 2 LPM – 91%, @ 10 LPM – 99+%VT-20 mls, Rate – 120 BPM:@ 2 LPM – 91%, @ 10 LPM – 99+ %VT-50 mls, Rate – 30 BPM:@ 2 LPM – 75%, @ 10 LPM – 99+%VT-50 mls, Rate – 60 BPM:@ 2 LPM – 66%, @ 10 LPM – 99+% | VT-20 mls, Rate – 60 BPM:@ 2 LPM – 82%, @ 5 LM – 97%@ 10 LPM – 98+% @ 15 LM – 99+%VT-150 mls, Rate – 25 BPM:@ 2 LPM – 50% @ 5 LM – 96%@ 10 LPM – 98+% @ 15 LM – 99+% |
| Expiratory resistance: | < 1.7 cm H2O @ 5 LPM | < 2.8 cm H2O @ 5 LPM |
| Inspiratory resistance: | < 1.3 cm H2O @ 5 LPM | < 2.8 cm H2O @ 5 LPM |
| Patient Valve malfunction: | < 6.0 cm H2O @ 30 LPM | < 6.0 cm H2O @ 30 LPM |
| Dead space: | 6.35 mls | 6.8 mls |
| Minimum / MaximumVolume: | 20 mls / 50 mls | 20 mls / 150 mls |
| Body mass range: | ≤3.3 Kg | ≤ 10.0 Kg |
| Pressure limitation: | 25 cm H2O ± 3.0 cm H2O with 40 cmH2O ± 5.0 cm H2O over-ride | 40 cm H2O ± 5.0 cm H2O with over-ride, unlimited pressure |
Conclusion:
Back Plus" Neonatal Manual Resuscitation bags are substantially equivalent in indication for use, environment of use, patient population design, material and function of the identified predicate.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Thomas C. Loescher President A Plus Medical 5431 Avenida Encinas, Suite G Carlsbad, California 92008
JAN 1 3 2012
Re: K112852
Trade/Device Name: Babi Plus™ Neonatal Resuscitation Bag Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: December 12, 2011 Received: December 13, 2011
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. 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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Page 2 - Mr. Loescher
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 yours,
hn for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
(To be assigned) 510(k) Number:
Bobl.Plus" Neonatal Resuscitation Bag
Device Name: Indications for Use:
Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3
Kg in hospital, transport, emergency and post hospital care environments.
Over-the-counter use Prescription Use X or (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(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-Uff) Oivision of Anesthesiology, General Hospital Infection Control, Dental Devices
11/2852 510(k) Number:
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).