The 1st Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of between 10 kg (22 lbs) and 40 kg (88 lbs).

Device Description

The 1st Response Pediatric manual resuscitator is a disposable, single use emergency manual ventilator. It is intended for single patient use only. Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservou or tube reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used. The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15 mm ID x 22 mm OD patient connector, exhalation port, manometer port and a pressure-limiting valve (PLV). The patient port has a swivel feature to allow the care provider to move the bag around the patient, as needed. Standard configurations of the device are provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.

AI/ML Overview

This document describes a 510(k) premarket notification for the "1st Response Pediatric Manual Resuscitator." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through extensive clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and training set information is not typically found in this type of regulatory submission.

Specifically, for this 510(k) K023793:

Acceptance Criteria and Reported Device Performance:
- The document states that "Performance and specifications of the modified device are consistent with all requirements for this device type specified by: ASTM 920; Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans, ISO 8382:1988 (E) Resuscitators intended for use with humans, and ISO 5356-1: 1987 - Anaesthetic and respiratory equipment - Conical connectors - Part 1; Cones and sockets."
- Interpretation: The acceptance criteria are defined by compliance with these established national and international standards for manual resuscitators. The reported device performance is implicitly stated as meeting these standards, as the submission concludes substantial equivalence. However, no specific performance metrics are provided in a table format in the document to directly compare against numerical acceptance criteria.
Sample Size used for the test set and the data provenance: Not applicable. This is a non-clinical submission relying on engineering and performance standards compliance, not a clinical study with a test set of patients/data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established by experts for a test set.
Adjudication method for the test set: Not applicable. No clinical test set was used.
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 device is a manual resuscitator, not an AI-assisted diagnostic tool or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and effectiveness determination is established by its adherence to recognized industry standards (ASTM and ISO as listed above) and by demonstrating substantial equivalence to predicate devices that have previously met regulatory requirements.
The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/machine learning device. The design and testing are based on engineering principles and regulatory standards.
How the ground truth for the training set was established: Not applicable.

Summary

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K023793

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Portex, Inc.

10 Bownlan Drive Keene NH 03431-0724 USA Tel: 603 352 3812 www.portexusa.com

H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) SUMMARY:

COMPANY INFORMATION:

Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Cynthia Engelhardt Technical Writer, Regulatory Affairs

PREPARATION DATE OF SUMMARY:

February, 10, 2003

TRADE NAME:

1st Response Pediatric Manual Resuscitator

COMMON NAME:

Manual Resuscitator

PRODUCT CLASS/CLASSIFICATION:

Class II, 73 BTM, 21 CFR 868.5915

PREDICATE DEVICE(S):

Portex, Inc., Ft. Myers Florida, 1" Response Manual Resuscitators, Cat. No. S500, 8503, 8506, 8520 and 8520B.

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DESCRIPTION:

The 18 Response Pediatic manual resuscitator is a disposable, single use emergency manual ventilator. It is intended for single patient use only.

Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of two types of reservoirs; bag reservou or tube reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used.

The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15 mm ID x 22 mm OD patient connector, exhalation port, manometer port and a pressure-limiting valve (PLV). The patient port has a swivel feature to allow the care provider to move the bag around the patient, as needed.

Standard configurations of the device are provided with or without a face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.

INDICATIONS FOR USE:

The 1ª Response Pediatric Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of between 10 kg (22 lbs) and 40 kg (881bs).

TECHNICAL CHARACTERISTICS:

: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The device has the same technical characteristics found in either the adult device we have authorization to market under premarket notification K014115 or the same technical characteristics found in the pediatric device we have authorization to market under premarket notification K991861.

NON-CLINICAL DATA:

Performance and specifications of the modified device are consistent with all requirements for this device type specified by: ASTM 920; Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans, ISO 8382:1988 (E) Resuscitators intended for use with humans, and ISO 5356-1: 1987 - Anaestheric and respiratory equipment - Conical connectors - Part 1; Cones and sockets.

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CONCLUSION:

The comparison to the predicate device demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

PORTEX, INC.

Cynthia Engelhardt Technical Writer, Regulatory Affairs

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three intertwined snakes around a staff. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2003

Ms. Cindy Engelhardt Portex, Incorporated 10 Bowman Drive Keene. New Hampshire 03431

Re: K023793

Trade/Device Name: 1st Response Pediatric Manual Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: November 12, 2002 Received: November 13, 2002

Dear Ms. Engelhardt:

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 such 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. You must comply with all the Act's requirements, including, but not limited to: registration

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Page 2 - Ms. Cindy Engelhardt

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Suser Rumpa

Susan Runner, DDS, MA Interim 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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B: INTENDED USE OF DEVICE

PROPOSED INDICATIONS FOR USE:

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510(k) Number (if known): Homous KO23793

Device Name: 1* Response Pediatric Manual Resuscitator

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use*$\qquad$OR Over-The-Counter Use*

Regulation Number and Section

§ 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).