(83 days)
Single patient use non self-inflating manual resuscitator for use in hospital and transport to temporary ventilate neonate, infant and pediatric patients. The pressure manometer in this product provides a visual indication of airway pressure during ventilation.
Single patient use hyperinflation bag with pressure manometer offered in 0.25, 0.50 and 1.0 liter ventilation bag sizes. End user manipulates gas flow and respiratory rate and exhalation port to control amount of gas, inspiratory pressure supplied to the patient. Each device has an integrated 0 - 60 cm H2O pressure manometer.
The provided text describes the Venti.Plus Hyperinflation Bag System with Pressure Manometer. While it mentions performance characteristics and equivalence to a predicate device, it does not detail specific acceptance criteria or a dedicated study in the format requested (i.e., a table of acceptance criteria and reported device performance). It primarily focuses on demonstrating substantial equivalence based on indications for use, environment of use, patient population, materials, and overall function, referencing bench testing and adherence to an ISO standard for connectors.
Here's a breakdown of the information that is available in relation to your questions, and what is missing:
Information Provided in the Document:
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A table of acceptance criteria and the reported device performance: This is not explicitly provided in a table format. The document states:
- "Bench testing confirmed that the A Plus Medical Venti.Plus Hyperinflation System with Pressure Manometer and predicate device have similar performance characteristics and the accuracy of the integrated pressure manometer in the Venti.Plus Hyperinflation System with Pressure Manometer is equivalent to the predicate device when used with its associated pressure manometer."
- It also states that both the device and predicate meet "the requirements set forth ISO 5356- 1:2004 entitled 'Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets'." This ISO standard likely contains specific acceptance criteria for conical connectors, but the document doesn't extract or list them.
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Sample size used for the test set and the data provenance: This information is not mentioned. The document refers to "bench testing" but provides no details on the sample size of devices tested or the origin of any data (e.g., retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not mentioned. The "bench testing" does not involve human readers or experts establishing ground truth in the context of diagnostic performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable as there is no mention of a test set requiring adjudication in this context.
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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: This is not applicable. The device is a manual resuscitator with a pressure manometer, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "accuracy of the integrated pressure manometer," the ground truth would presumably be a calibrated reference pressure measurement device. For the "similar performance characteristics," it would involve comparing the Ventin.Plus to the predicate device under various testing conditions, with the predicate serving as a benchmark. For the ISO standard, the ground truth would be the specifications outlined in the standard. However, the document does not explicitly state the type of ground truth or reference standards used for the performance comparisons.
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The sample size for the training set: This is not applicable as it's not an AI/machine learning device.
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How the ground truth for the training set was established: This is not applicable.
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(a) A Plus Medical
Solutions for Respiratory Care
510(k) Summary
NOV 2 8 2009
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:
VESSA.Plus" Hyperinflation Bag System with Pressure Manometer
Common/Usual Name:
Hyperinflation Bag with Pressure Manometer
Classification Name:
| Device Name: | Resuscitator, Manual, Non Self-Inflating |
|---|---|
| Product Code: | NHK |
| Regulation: | CFR 868.5905 |
| Device Class: | II |
| Device Name: | Monitor, Airway Pressure |
| Product Code: | CAP |
| Regulation: | CFR 868.2600 |
| Device Class: | II |
Device:
4.2
Venti*Plus Hyperinflation Bag System with Pressure Manometer
Predicate Devices:
| Number: | K970785 |
|---|---|
| Product Name: | SIMS Hyperinflation Bag System |
| Manufacturer: | Smiths Medical (Intertech Resources) |
| Product Codes: | 008330DM, 008330VM, 008332DM, 008335DM,008430, 008430DM, 00843M, 008430T,,008430VM, 008431T, 008432, 008432DM,008432T, 008435 & 008435DM |
| Number: | K961318 |
| Product Name: | 1st Response Disposable Manometer |
| Manufacturer: | Smiths Medical (Intertech Resources) |
| Product Codes: | 008201 |
5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 盆 +740-930-4025 Fax: +760-930-0040
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Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical. The logo features the letter A inside of a circle on the left. To the right of the circle is the text "A Plus Medical" in a bold font. Below the company name is the text "Solutions for Respiratory Care" in a smaller font.
Device Description:
Single patient use hyperinflation bag with pressure manometer offered in 0.25, 0.50 and 1.0 liter ventilation bag sizes. End user manipulates gas flow and respiratory rate and exhalation port to control amount of gas, inspiratory pressure supplied to the patient. Each device has an integrated 0 - 60 cm H2O pressure manometer.
Indications for Use:
Single patient use non self-inflating manual resuscitator for use in hospital and transport to temporary ventilate neonate, infant and pediatic patients. The pressure manometer in this provides a visual indication of arway pressure during ventilation.
Contraindications:
None identified.
Patient Population:
Patient populations of neonate, newborn and pediatric.
Environment of Use:
Hospital and patient transport
Comparative of Technological Characteristics:
The A Plus Medical Ventit Plus Hyperinflation System with Pressure Manometer is substantially equivalent in indications for use, environment of use, patient population, material and function to the identified predicate. The A Plus Medical Ventif Plus Hyperinflation System with Pressure Manometer 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 that the A Plus Medical VentiPlus Hyperinflation System with Pressure Manometer and predicate device have similar performance characteristics and the accuracy of the integrated pressure manometer in the VentiPlus Hyperinflation System with Pressure Manometer is equivalent to the predicate device when used with its associated pressure manometer.
Conclusion:
The Venti*Plus Hyperinflation System with Pressure Manometer is substantially equivalent to the identified predicates. The Ventif Plus Hyperinflation System with Pressure Manometer and the identified predicates have substantially equivalent performance.
The Ventif Plus Hyperinflation System with Pressure Manometer and the identified predicates are made from substantially equivalent material, intended use, patient populations and environment of use
5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 2. +740-930-4025 Fax: +760-930-0040 ~ 14~
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Thomas C. Loescher, R.R.T. President A Plus Medical 5431 Avenida Encinas, Suite G Carlsbad, California 92008-4411
NOV 2 3 2009
Re: K092687
Trade/Device Name: Venti.Plus™ Hyperinflation Bag System with Pressure Manometer Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NHK Dated: November 4, 2009 Received: November 10, 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.
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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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting Division 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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Image /page/4/Picture/0 description: The image shows the logo for A Plus Medical. The logo features the letter 'a' inside of a parenthesis. The text 'A Plus Medical' is to the right of the parenthesis, and the text 'Solutions for Respiratory Care' is below 'A Plus Medical'.
Indications for Use Statement
510(k) Number:
."
KD92689 (To be assigned)
Device Name: Indications for Use: VENEA. Plus" Hyperinflation Bag System with Pressure Manometer
Single patient use non self-inflating manual resuscitator for use in hospital and transport to temporary ventilate neonate, infant and pediatric patients. The pressure manometer in this product provides a visual indication of airway pressure during ventilation.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Y. Schutte
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092687
§ 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).