HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100

K062119 · Medical Products Mfg., LLC · DRM · Sep 22, 2006 · Cardiovascular

Device Facts

• Record ID: K062119
• Device Name: HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
• Applicant: Medical Products Mfg., LLC
• Product Code: DRM · Cardiovascular
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended to be used as adjuncts to manual CPR on patients in cardiac arrest. The HLR Model-601 and the HeartSaver 100 are designed for use on adults or large children and should be administered by trained medical personnel.

Device Story

HLR Model-601 and HeartSaver 100 are compact, portable, air-powered automatic CPR devices; used as adjuncts to manual CPR for patients in cardiac arrest. Devices provide automatic chest compressions and ventilation; user-selectable ratios include 30:2, 15:2, or continuous chest compressions without ventilation. Operated by trained medical personnel in emergency settings. Controls allow adjustment of compression depth and ventilation volume. Benefits include consistent, automated resuscitation support for non-breathing, pulseless patients.

Clinical Evidence

Bench testing only; verification and validation testing demonstrated conformance to design and performance specifications.

Technological Characteristics

Air-powered automatic CPR device; compact, portable form factor. Provides mechanical chest compressions and ventilation. User-adjustable compression depth and ventilation volume. No software or electronic sensing described.

Indications for Use

Indicated for use as adjuncts to manual CPR on non-breathing, unconscious, pulseless patients in urgent need of cardiopulmonary resuscitation; intended for adults or large children.

Regulatory Classification

Identification

An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use. (2) Labeling must include the following: (i) The clinical training necessary for the safe use of this device; (ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling; (iii) Information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations, *e.g.,* adult, pediatric and/or infant); and(iv) Information on the time necessary to deploy the device as demonstrated in the performance testing. (3) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment. (4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device. (5) For devices containing software, software verification, validation, and hazard analysis must be performed. (6) Components of the device that come into human contact must be demonstrated to be biocompatible.

Predicate Devices

• HLR PARA-MED Heart Lung Resuscitator

Submission Summary (Full Text)

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# MEDICAL PRODUCTS MFG. LLC

## SPECIAL 510K

### 510(k) Summary HLR™ Model-601 Heart Lung Resuscitator and HeartSaver 100

### 1. SPONSOR

Medical Products Mfg., LLC. 6 Thacher Lane Wareham, MA 02571 508-291-1830

SEP 2 2 2006

Contact: John R. Driscoll, General Manager

Date Prepared: July 24, 2006

### DEVICE NAME 2.

: :

Proprietary Name: HLRTM Model-601 and HeartSaver 100 Common/Usual Name: Heart-lung resuscitator Classification Name: Unclassified

#### PREDICATE DEVICES 3.

Pre-Amendment HLR® PARA-MED™ Heart Lung Resuscitator

#### DEVICE DESCRIPTION 4.

HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are modifications to the pre-Amendment HLR® PARA-MED™ Heart Lung Resuscitator. The HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are compact, totally portable, automatic CPR Devices. The HLR Model-601 and the HeartSaver 100 are air-powered medical devices used for emergency resuscitation of patients who have stopped spontaneous breathing. The HLR Model-601 and the HeartSaver 100 provide automatic chest compressions and ventilation per the current American Heart Association Guidelines. The devices can control the depth of chest compressions and the volume of ventilation. The HLR Model-601 and the HeartSaver 100 allow the trained user three options of compression to ventilation ratios (30:2), (15:2) and continuous chest compressions without ventilation.

July 24, 2006

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MEDICAL PRODUCTS MFG. LLC.

### SPECIAL 510K

#### ട്. INTENDED USE

The HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended to be used as adjuncts to manual CPR on patients in cardiac arrest. The HLR Model-601 and the HeartSaver 100 are designed for use on adults or large children and should be administered by trained medical personnel.

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The HLR Model-601 and the HeartSaver 100 are substantially equivalent to the parent device for intended use and indications for use as well as the basic overall functions.

#### 7. PERFORMANCE TESTING

Verification and validation testing demonstrated that the modified devices, the HLR Model-601 and the HeartSaver 100 conform to design and performance specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

### SEP 2 2 2006

Medical Products Manufacturing, LLC c/o Mr. John R. Driscoll General Manager 6 Thacher Lane Wareham, MA 02571

Re: K062119

HLRTM Model 601 Heart Lung Resuscitator and Heartsaver 100 Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class II (two) Product Code: DRM Dated: September 14, 2006 Received: September 15, 2006

Dear Mr. Driscoll:

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. John R. Driscoll

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 that I Drineal statutes and regulations administered by other Federal agencies. You must or any i 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-dessions 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/industry/support/index.html.

Sincerely yours,

prima R. Willing

Image /page/3/Picture/6 description: The image shows a handwritten signature or symbol on the left, followed by the letters 'E' and 'D' on the right. The signature appears to be a stylized, looping design, possibly initials. The letters 'E' and 'D' are printed in a simple, sans-serif font and are positioned closely together.

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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## MEDICAL PRODUCTS MFG. LLC.

### SPECIAL 510K

K062119 510(k) Number (if known):

Device Name: HLR™ Model-601 Heart Lung Resuscitator and HeartSaver 100

Indications For Use:

The HLR™ Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended for use as adjuncts to manual CPR on patients who are non-breathing, unconscious, pulseless and in urgent need of cardiopulmonary resuscitation.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. V. Aunes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 062119