RESQPOD CIRCULATORY ENHANCER

K022906 · Cprx, LLC · BWF · Jun 11, 2003 · Anesthesiology

Device Facts

• Record ID: K022906
• Device Name: RESQPOD CIRCULATORY ENHANCER
• Applicant: Cprx, LLC
• Product Code: BWF · Anesthesiology
• Decision Date: Jun 11, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

ResQPOD Circulatory Enhancer is a patient-powered pump; utilizes patient's own negative intrathoracic pressures to create vacuum in chest cavity. Vacuum facilitates heart preload with increased blood volume; results in increased blood circulation. Used in home and hospital settings; operated by patient under physician/licensed practitioner prescription. Output is physiological (increased circulation); intended to benefit patients with poor circulation. Safety/effectiveness not established for pregnant women, children under 18, patients with hypovolemia, arterial stenosis, or asthma.

Clinical Evidence

No human clinical data provided. Evidence consists of non-clinical bench testing and animal studies demonstrating increased circulation with device use.

Technological Characteristics

Patient-powered pump; utilizes negative intrathoracic pressure. No external energy source. Mechanical design similar to incentive spirometer. No specific materials or software algorithms described.

Indications for Use

Indicated for home and hospital use for temporary increase in blood circulation in patients with poor circulation, as prescribed by a physician or licensed practitioner. Contraindicated in patients with chest pain, shortness of breath, dilated cardiomyopathy, congestive heart failure, pulmonary hypertension, aortic stenosis, or flail chest.

Regulatory Classification

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.

Predicate Devices

• Compressible Limb Sleeve (JOW)
• Spirometer, Therapeutic (Incentive) (BWF)

Reference Devices

• PPCID- Pneumatic Peripheral Circulation Improvement (K000655)

Submission Summary (Full Text)

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## 'JUN 1 1 2003

Appendix 2: Revised 510(k) Summary and Indication for Use Form

K022906
A2-13

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## 510(k) Summary

| 1. Submitter: | Advanced Circulatory Systems, Inc.<br>7615 Golden Triangle Drive<br>Suite A<br>Eden Prairie, MN 55344<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact: | Meg Stapleton<br>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)<br>Class 2 |
| | Spirometer, Therapeutic (Incentive) (BWF)<br>Class 2 |
| 7. Description: | The ResQPOD Circulatory Enhancer is a patient<br>powered pump that uses a person's own negative<br>intrathoracic pressures to create a vacuum in the chest<br>cavity. The vacuum allows the heart to preload with<br>more blood, thereby increasing blood circulation. |
| 8. Intended use: | The ResQPOD Circulatory Enhancer is indicated for use<br>in people with poor circulation. |
| | The ResQPOD Circulatory Enhancer is indicated for<br>home and hospital use for the temporary increase in<br>blood circulation as prescribed by a physician or<br>licensed practitioner. |
| 9. Contraindications | The ResQPOD Circulatory Enhancer is contraindicated<br>in persons with:<br>1. chest pain; |
| | 2. shortness of breath;<br>3. dilated cardiomyopathy and/or congestive heart<br>failure;<br>4. pulmonary hypertension and/or aortic stenosis; and,<br>5. flail chest. |
| 10. Warnings | Safety and effectiveness in users suffering from arterial<br>stenosis or asthma has not been established.<br>Prescribing physicians or licensed practitioners should<br>be aware of these conditions before prescribing use. |
| 11. Precautions | The safety and effectiveness in pregnant women and<br>children under the age of 18, and patients with<br>hypovolemia, has not been established. Special care<br>should be exercised for the safe and effective use of this<br>device by such persons. |
| 12. Technology comparison to predicate device(s): | The ResQPOD Circulatory Enhancer is similar in<br>technological design to an Incentive Spirometer (BWF<br>Class 2). The Indication of increased circulation is the<br>same as the PPCID- Pneumatic Peripheral Circulation<br>Improvement (K000655). |
| 13. Non-clinical test summary: | Substantial equivalence to predicate devices was<br>provided, in part, by non-clinical tests that demonstrate<br>substantially equivalent product technology. |
| | |
| | Animal studies demonstrated an increase in circulation<br>with the use of the ResQPOD Circulatory Enhancer<br>device. |
| 14. Conclusion: | The ResQPOD Circulatory Enhancer is substantially<br>equivalent to the legally marketed predicate devices. No<br>new 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 [phone]. 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 [phone] or [phone] 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