PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS

K072572 · Lifecore Biomedical, Inc. · NHA · Oct 5, 2007 · Dental

Device Facts

• Record ID: K072572
• Device Name: PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS
• Applicant: Lifecore Biomedical, Inc.
• Product Code: NHA · Dental
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

AutoPulse Resuscitation System Model 100 is an automated, portable, battery-powered mechanical chest compressor. Device consists of a reusable platform containing a user control panel, drive mechanism, control system, and rechargeable battery, plus a single-use chest compression assembly (CCA) with a patient liner. Used as an adjunct to manual CPR to provide chest compressions for adult patients in clinical death. Device operates by applying mechanical compressions to the patient's chest. Intended for use by healthcare providers in clinical settings to assist in resuscitation efforts, potentially improving consistency of compressions compared to manual CPR.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Portable, battery-powered mechanical chest compressor. Components: reusable platform (control panel, drive mechanism, control system, battery) and single-use chest compression assembly (CCA) with patient liner. Materials are biocompatible and previously cleared. No specific software architecture or connectivity details provided.

Indications for Use

Indicated for adult patients in clinical death (lack of spontaneous breathing and pulse) as an adjunct to manual CPR.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• AutoPulse® Resuscitation System Model 100 (K063602)

Submission Summary (Full Text)

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### 510(k) Summary

# MAR 1 9 2008

| "Concernal proposes | General Information |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

| 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.<br>249 Humboldt Court<br>Sunnyvale, CA 94089 |
| | Phone: [phone]<br>Fax: [phone] |
| Contact | Mark Perkins<br>Director, Quality Assurance and Regulatory Affairs |
| Date Prepared | September 5, 2007 |

Intended Use

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.

#### Predicate Devices

K063602 AutoPulse® Resuscitation System Model 100

## 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).

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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 [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,

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 is<br>intended to be used as an adjunct to manual CPR, on adult<br>patients only, in cases of clinical death as defined by lack<br>of spontaneous breathing and pulse. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

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(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________________________________________________________________________________________________________________________________________________________________