(59 days)
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.
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.
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 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.
The provided text describes a Special 510(k) submission for the HLR™ Model-601 Heart Lung Resuscitator and HeartSaver 100. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific performance acceptance criteria.
Based on the provided text, the following information can be extracted regarding acceptance criteria and a "study":
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to design and performance specifications | "Verification and validation testing demonstrated that the modified devices, the HLR Model-601 and the HeartSaver 100 conform to design and performance specifications." |
| Substantial equivalence to predicate device in intended use, indications for use, and basic overall functions | "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." |
| Provision of automatic chest compressions and ventilation per current American Heart Association Guidelines | "The HLR Model-601 and the HeartSaver 100 provide automatic chest compressions and ventilation per the current American Heart Association Guidelines." |
| Ability to control depth of chest compressions and volume of ventilation | "The devices can control the depth of chest compressions and the volume of ventilation." |
| Offering three options of compression to ventilation ratios (30:2), (15:2) and continuous chest compressions without 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." |
| Intended for use as adjuncts to manual CPR on patients in cardiac arrest (non-breathing, unconscious, pulseless) | Stated as the "Indications For Use" and "Intended Use" for both devices. |
| Designed for use on adults or large children | Stated in "Intended Use". |
| Administered by trained medical personnel | Stated in "Intended Use". |
Note: The document states that "Verification and validation testing demonstrated that the modified devices... conform to design and performance specifications," but it does not provide the specific numerical acceptance criteria for these specifications or the raw data/results of said testing. The primary "study" referred to is the comparison to the predicate device to establish substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "Verification and validation testing" without detailing the number of units tested or specific test cases.
- Data Provenance: Not specified. It's likely that the testing was conducted internally by Medical Products Mfg., LLC, but the country of origin of testing data or whether it was retrospective/prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The submission relies on "Verification and validation testing" and a claim of conformance to specifications and substantial equivalence, not a review by external experts to establish a "ground truth" for a test set in the context of AI/diagnostic device evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. As the document does not detail an expert review process for a test set, there is no mention of an adjudication method.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a medical device for resuscitation, not an AI-powered diagnostic or assistive tool for human readers. It functions as an automatic CPR device.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an AI algorithm. The device, the HLR™ Model-601 and HeartSaver 100, is a standalone medical device designed to perform automatic CPR without continuous human intervention during the resuscitation action, although it is administered by trained medical personnel. The "performance testing" mentioned effectively serves as the standalone performance evaluation for the device's mechanical and operational functions against its design specifications and AHA guidelines. The document states it "provide automatic chest compressions and ventilation."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology for disease presence) is not applicable here in the traditional sense. For this device, the "ground truth" for its performance is its conformance to established engineering design and performance specifications, and its ability to deliver CPR parameters (compression depth, ventilation volume, ratios) as defined by the current American Heart Association Guidelines. Whether these guidelines were strictly adhered to and measured during verification and validation testing would constitute the "ground truth" for device operation.
8. The sample size for the training set:
- Training Set: Not applicable. This is a physical medical device, not an AI algorithm that undergoes training.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.
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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 (240) 276-0120. 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/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
§ 870.5200 External cardiac compressor.
(a)
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).(b)
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.