The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

Device Description

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

AI/ML Overview

This document is a 510(k) Summary for the AutoPulse® Resuscitation System Model 100, which is an external cardiac compressor. The summary primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, performance metrics, or study designs typically found in clinical validation studies.

Therefore, I cannot provide the requested information such as a table of acceptance criteria and reported device performance, sample sizes for test or training sets, data provenance, details on expert opinion for ground truth, or adjudication methods, as these details are not present in the provided text.

The document states that "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device. Testing of the device modifications demonstrates the device meets and improves upon the predicate device." However, no specific performance metrics or the results of these tests are provided.

The provided text focuses on the regulatory submission process and the determination of substantial equivalence, rather than a clinical study evaluating defined performance criteria.

Summary

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510(k) Summary

MAR 1 9 2008

"Concernal proposes	General Information
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Classification	Class III
Trade Name	AutoPulse® Resuscitation System Model 100
Common Name	Automatic Mechanical Chest Compressor
Classification Name	External Cardiac Compressor 870.5200
Submitter	ZOLL Circulation, Inc.249 Humboldt CourtSunnyvale, CA 94089
	Phone: 408-541-2140Fax: 408-514-1030
Contact	Mark PerkinsDirector, Quality Assurance and Regulatory Affairs
Date Prepared	September 5, 2007

Intended Use

Predicate Devices

K063602 AutoPulse® Resuscitation System Model 100

Device Description

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Materials

All materials used in the manufacture of the AutoPulse Resuscitation System Model 100 are suitable for this use and have been used in numerous previously cleared products.

Testing:

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device. Testing of the device modifications demonstrates the device meets and improves upon the predicate device.

Summary of Substantially Equivalence:

The AutoPulse Resuscitation System Model 100 is equivalent to the predicate device. The indications for use, basic overall function, and materials used have been determined to be substantially equivalent.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2008

Zoll Circulation, Inc. c/o Mr. Mark Perkins Director of Quality Assurance and Regulatory Affairs 249 Humboldt Court Sunnyvale, CA 94089

K072527 Re:

AutoPulse® Resuscitation System Model 100 Regulation Number: 870.5200 Regulation Name: Compressor, Cardiac External Regulatory Class: Class III (three) Product Code: DRM Dated: February 19, 2008 Received: February 22, 2008

Dear Mr. Perkins:

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. Mark Perkins

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 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Q.S.Kl

CR 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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Indications for Use

510(k) Number (if known): This Application	K072572
Device Name:	AutoPulse® Resuscitation System Model 100
Indications For Use:	The AutoPulse Resuscitation System Model 100 isintended to be used as an adjunct to manual CPR, on adultpatients only, in cases of clinical death as defined by lackof spontaneous breathing and pulse.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q.S.M.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)