(281 days)
No
The device description and performance studies focus on mechanical principles and animal studies, with no mention of AI/ML terms or data processing.
Yes
The device is indicated for temporarily increasing blood circulation in people with poor circulation, which directly addresses a medical condition or health problem.
No
Explanation: The device description states its purpose is to "increase blood circulation" by "increasing the heart to preload with more blood." This indicates a therapeutic function rather than a diagnostic one. It doesn't measure, analyze, or provide information about a patient's condition but rather acts to improve a physiological function.
No
The device description explicitly states it is a "patient powered pump" and uses "negative intrathoracic pressures to create a vacuum," which describes a physical, hardware-based mechanism, not a software-only device.
Based on the provided information, the ResQPOD™ Circulatory Enhancer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ResQPOD Function: The ResQPOD™ Circulatory Enhancer is a mechanical device that physically interacts with the patient's body (using negative intrathoracic pressure) to improve blood circulation. It does not perform any tests on biological samples.
The description clearly indicates it's a patient-powered pump that affects the mechanics of the circulatory system, not a device for analyzing biological samples.
N/A
Intended Use / 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.
Product codes
BWF, JOW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and hospital use, as prescribed by a physician or licensed practitioner.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical test summary: Substantial equivalence to predicate devices was provided, in part, by non-clinical tests that demonstrate substantially equivalent product technology. Animal studies demonstrated an increase in circulation with the use of the ResQPOD Circulatory Enhancer device.
Key Metrics
Not Found
Predicate Device(s)
Compressible Limb Sleeve (JOW), Spirometer, Therapeutic (Incentive) (BWF)
Reference Device(s)
PPCID- Pneumatic Peripheral Circulation Improvement (K000655)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
'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 Drive
Suite A
Eden Prairie, MN 55344
Tel: 952.947.9590
Fax: 952.942.8336 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact: | Meg Stapleton
Advanced 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 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. |
| 8. Intended use: | 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. |
| 9. Contraindications | The ResQPOD Circulatory Enhancer is contraindicated
in persons with:
- chest pain; |
| | 2. shortness of breath; - dilated cardiomyopathy and/or congestive heart
failure; - pulmonary hypertension and/or aortic stenosis; and,
- flail chest. |
| 10. Warnings | Safety and effectiveness in users suffering from arterial
stenosis or asthma has not been established.
Prescribing physicians or licensed practitioners should
be aware of these conditions before prescribing use. |
| 11. Precautions | The safety and effectiveness in pregnant women and
children under the age of 18, and patients with
hypovolemia, has not been established. Special care
should be exercised for the safe and effective use of this
device by such persons. |
| 12. Technology comparison to predicate device(s): | The ResQPOD Circulatory Enhancer is similar in
technological design to an Incentive Spirometer (BWF
Class 2). The Indication of increased circulation is the
same as the PPCID- Pneumatic Peripheral Circulation
Improvement (K000655). |
| 13. Non-clinical test summary: | Substantial equivalence to predicate devices was
provided, in part, by non-clinical tests that demonstrate
substantially equivalent product technology. |
| | |
| | Animal studies demonstrated an increase in circulation
with the use of the ResQPOD Circulatory Enhancer
device. |
| 14. Conclusion: | The ResQPOD Circulatory Enhancer is substantially
equivalent to the legally marketed predicate devices. No
new questions of safety or effectiveness are raised. |
1
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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
3
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
4
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