(281 days)
The ResQPOD™ Circulatory Enhancer is indicated for use in people with poor circulation. The ResQPOD™ Circulatory Enhancer is indicated for home and hospital use for the temporary increase in blood circulation as prescribed by a physician or licensed practitioner.
The ResQPOD Circulatory Enhancer is a patient powered pump that uses a person's own negative intrathoracic pressures to create a vacuum in the chest cavity. The vacuum allows the heart to preload with more blood, thereby increasing blood circulation.
The provided text is a 510(k) summary for the ResQPOD™ Circulatory Enhancer and the associated FDA approval letter. It outlines the device description, intended use, predicate devices, and a non-clinical test summary. However, it does not contain detailed information about acceptance criteria, specific device performance metrics, the setup of a study proving those metrics, sample sizes, expert qualifications, adjudication methods, or direct comparisons with human readers.
Therefore, many of the requested categories cannot be filled from the provided text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: The document states "Animal studies demonstrated an increase in circulation with the use of the ResQPOD Circulatory Enhancer device." This is a qualitative statement, not a quantitative performance metric.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Animal studies demonstrated an increase in circulation with the use of the ResQPOD Circulatory Enhancer device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified. The study mentioned is "animal studies," so the "test set" would refer to the animals in these studies.
- Data Provenance: Not specified, beyond being "Animal studies." It doesn't mention country of origin, retrospective, or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. The study mentioned is an animal study demonstrating an increase in circulation. Ground truth in this context would likely be physiological measurements, not expert interpretation of outputs.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for subjectively interpreted data by human experts, which is not the case for animal studies measuring physiological responses.
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
- No. This is explicitly not an AI device and not an MRMC study. The device is a patient-powered pump designed to physically enhance circulation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device is a physical circulatory enhancer, not an algorithm. So, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth in the "animal studies" would have been physiological measurements demonstrating an increase in circulation, likely direct measurements of blood flow or pressure, rather than expert consensus, pathology, or outcomes data in the traditional sense of diagnostic devices.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, and thus there is no "training set" in the computational sense. The "animal studies" were likely part of the investigational work to confirm the device's mechanism of action.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI device.
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'JUN 1 1 2003
Appendix 2: Revised 510(k) Summary and Indication for Use Form
K022906
A2-13
。
510(k) Summary
| 1. Submitter: | Advanced Circulatory Systems, Inc.7615 Golden Triangle DriveSuite AEden Prairie, MN 55344Tel: 952.947.9590Fax: 952.942.8336 |
|---|---|
| 2. Contact: | Meg StapletonAdvanced Circulatory Systems, Inc. |
| 3. Date prepared. | June 9, 2003 |
| 4. Device trade name: | ResQPOD™ Circulatory Enhancer |
| 5. Common name: | Circulatory Enhancer |
| 6. Predicate device(s): | Compressible Limb Sleeve (JOW)Class 2 |
| Spirometer, Therapeutic (Incentive) (BWF)Class 2 | |
| 7. Description: | The ResQPOD Circulatory Enhancer is a patientpowered pump that uses a person's own negativeintrathoracic pressures to create a vacuum in the chestcavity. The vacuum allows the heart to preload withmore blood, thereby increasing blood circulation. |
| 8. Intended use: | The ResQPOD Circulatory Enhancer is indicated for usein people with poor circulation. |
| The ResQPOD Circulatory Enhancer is indicated forhome and hospital use for the temporary increase inblood circulation as prescribed by a physician orlicensed practitioner. | |
| 9. Contraindications | The ResQPOD Circulatory Enhancer is contraindicatedin persons with:1. chest pain; |
| 2. shortness of breath;3. dilated cardiomyopathy and/or congestive heartfailure;4. pulmonary hypertension and/or aortic stenosis; and,5. flail chest. | |
| 10. Warnings | Safety and effectiveness in users suffering from arterialstenosis or asthma has not been established.Prescribing physicians or licensed practitioners shouldbe aware of these conditions before prescribing use. |
| 11. Precautions | The safety and effectiveness in pregnant women andchildren under the age of 18, and patients withhypovolemia, has not been established. Special careshould be exercised for the safe and effective use of thisdevice by such persons. |
| 12. Technology comparison to predicate device(s): | The ResQPOD Circulatory Enhancer is similar intechnological design to an Incentive Spirometer (BWFClass 2). The Indication of increased circulation is thesame as the PPCID- Pneumatic Peripheral CirculationImprovement (K000655). |
| 13. Non-clinical test summary: | Substantial equivalence to predicate devices wasprovided, in part, by non-clinical tests that demonstratesubstantially equivalent product technology. |
| Animal studies demonstrated an increase in circulationwith the use of the ResQPOD Circulatory Enhancerdevice. | |
| 14. Conclusion: | The ResQPOD Circulatory Enhancer is substantiallyequivalent to the legally marketed predicate devices. Nonew questions of safety or effectiveness are raised. |
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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 a human figure in profile, with three overlapping lines forming the head and body. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2003
Advance Circulatory systems, Inc. Formerly CPRx c/o Ms. Meg Stapleton 7615 Golden Triangle Drive, Suite A Eden Prairies, MN 55344
Re: K022906
Trade Name: ResQPOD™ Circulatory Enhancer Regulation Number: 21 CFR 868.5690 and 870.5800 Regulation Name: Incentive spirometer and Compressible limb sleeve. Regulatory Class: Class II (two) Product Code: BWF and JOW Dated: March 12, 2003 Received: March 13, 2003
Dear Ms. Stapleton:
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
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Page 2 - Ms. Meg Stapleton
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) 594-4646. 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,
R. Dale Tiller, M.D.
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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Indication for Use Form
Page 1_ of __ 1
K022906 510(k) Number (if known):
ResOPOD™ Circulatory Enhancer Device Name:
Indications For Use:
The ResQPOD™ Circulatory Enhancer is indicated for home and hospital use, for the temporary increase in blood circulation as prescribed 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)
Prescription Use Only
(Optional Format 3-10-98)
N. Deaton
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K022906
§ 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).