The ResQPOD Circulatory Enhancer is indicated for home, hospital, clinic and emergency care use, for the temporary increase in blood circulation as directed by a physician or licensed practitioner.

Device Description

The modified ResQPOD Circulatory Enhancer (CE) device is mechanically and functionally equivalent to the unmodified, predicate ResQPOD CE reviewed and cleared for market in 510(k) K022906. This 510(k) submission was provided to review the following feature additions:
a) The addition of timing assist lights as a convenience to encourage proper inspiration rate through the ResQPOD CE;
b) Modified labeling to support use of the ResQPOD CE on alternative adjunctive airway devices, such as a mouthpiece, facemask with an ISO standard 22 mm connector, and endotracheal tube;
c) Provision for an ISO standard 15 mm to 22 mm adapter connector between the ResOPOD CE and the mouthpiece or facemask; and
d) Modified labeling to support use of the ResOPOD CE in clinic and emergency care locations with patients who, in the judgment of a physician or licensed professional, may need circulatory enhancement as provided by the ResQPOD CE.

AI/ML Overview

The provided text describes a 510(k) submission for a modified ResQPOD™ Circulatory Enhancer. It outlines the changes made to the device and asserts its substantial equivalence to a predicate device. However, the document does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document states that "The safety and effectiveness of use of the modified ResQPOD CE device was demonstrated by testing in compliance with the Design Control process." However, it does not specify what those acceptance criteria were (e.g., specific performance metrics, thresholds) nor does it report any quantitative performance results from such testing.

2. Sample Size Used for the Test Set and Data Provenance

Missing. The document refers to "testing in compliance with the Design Control process" but does not provide any specifics about a test set, its sample size, or the provenance of the data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Missing. Given that no specific test set or performance evaluation is detailed, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

Missing. No information on adjudication methods is present.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Missing. There is no mention of an MRMC study or any comparative effectiveness study involving human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Missing. This device is a mechanical circulatory enhancer, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable here.

7. The Type of Ground Truth Used

Missing. As no specific performance data or studies are detailed, the type of ground truth used is not mentioned.

8. The Sample Size for the Training Set

Missing. No training set is mentioned as this device is not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Missing. Not relevant as it's not an AI/ML device.

Summary of available information related to acceptance criteria and study:

The document states that the modified device is "mechanically and functionally equivalent to the unmodified, predicate ResQPOD CE" and that its "intended use and technology...is substantially equivalent to the predicate, unmodified device." The primary basis for the 510(k) submission is to review feature additions and modified labeling, not to demonstrate new performance insights through extensive clinical trials.

The "study" referred to is the internal "testing in compliance with the Design Control process." This implies that the device satisfied internal design verification and validation requirements, but these are not explicitly detailed in terms of public acceptance criteria or reported performance metrics within this 510(k) summary. The FDA's letter acknowledges this submission as a review for "substantial equivalence" to the predicate device, meaning its safety and effectiveness are deemed comparable, without requiring extensive new clinical performance data to be presented in this document.

Summary

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K033401

Advanced Circulatory Systems, Inc.

7615 Golden Triangle Drive (Suite A) Eden Prairie, MN 55344 (952) 947-9590 (telephone) (952) 942-8336 (facsimile)

510(k) Summary of Safety and Effectiveness

Company Name:	Advanced Circulatory Systems, Inc.7615 Golden Triangle Drive (Suite A)Eden Prairie, MN 55344
Contact:	Robert Cohen, Chief Executive Officer
Phone:	952 947-9615
Fax:	952 942-8336
Summary Date:	October 23, 2003
Trade Name:	ResQPOD™ Circulatory Enhancer
Common Name:	Circulatory Enhancer
Classification Name:	The unmodified, predicate ResQPOD CE was found substantiallyequivalent to:21 CFR 868.5690 Incentive Spirometer21 CFR 870.5800 Compressible Limb Sleeve

Predicate Device:

510(k)	Manufacturer	Product Code	Class	Trade Name
K022906	AdvancedCirculatorySystems, Inc.	BWF, JOW	II	ResQPOD™ CirculatoryEnhancer

1.0 Description of Device

a) The addition of timing assist lights as a convenience to encourage proper inspiration rate through the ResQPOD CE;
b) Modified labeling to support use of the ResQPOD CE on alternative adjunctive airway devices, such as a mouthpiece, facemask with an ISO standard 22 mm connector, and endotracheal tube;

2017年07月24日 10:47:00 PM 2017 07:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 1

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c) Provision for an ISO standard 15 mm to 22 mm adapter connector between the ResOPOD CE and the mouthpiece or facemask; and
d) Modified labeling to support use of the ResOPOD CE in clinic and emergency care locations with patients who, in the judgment of a physician or licensed professional, may need circulatory enhancement as provided by the ResQPOD CE.

2.0 Intended Use

The modified ResQPOD CE indication for use is:

The ResQPOD Circulatory Enhancer is indicated for home, hospital, clinic and emergency care use, for the temporary increase in blood circulation as directed by a physician or licensed practitioner.

3.0 Technological

The technology of the modified ResQPOD CE device for temporary increase in circulation is the same as the technology of the ResQPOD CE device, reference 510(k) K022906.

The modified ResQPOD CE device is applied to adjunctive airway devices such as a mouthpiece, facemask or endotracheal tube. The skin contact material components of the modified ResQPOD CE are the same as those reviewed and cleared to market with the ResQPOD CE, 510(k) K022906 and are commercially available devices for respiratory use.

4.0 Conclusions

The safety and effectiveness of use of the modified ResQPOD CE device was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the modified ResOPOD CE device is substantially equivalent to the predicate, unmodified device. No new questions of safety or effectiveness are raised.

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Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three parallel lines representing the human form. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Advanced Circulatory Systems Incorporated c/o Mr. Gary Syring Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589

Re: K033401

Modified ResQPOD™ Circulatory Enhancer Regulation Number: 21 CFR 868.5690 and 21 CFR 870.5800 Regulation Name: Incentive Spirometer and Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: BWF and JOW Dated: October 23, 2003 Received: October 29, 2003

Dear Mr. Syring:

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.

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Page 2 - Mr. Gary Syring

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); 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. 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) 594-4648. 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,

Megan May

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1033401 510(k) Number (if known): _

Device Name: _ResQPOD Circulatory Enhancer, Modified

Indications For Use:

The ResQPOD Circulatory Enhancer is indicated for home, hospital, clinic and emergency care use, for the temporary increase in blood circulation as directed by a physician or licensed practitioner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Crefan mase

ovascular Devices

510(k) Number

(Optional Format 3-10-98)

Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).