ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR

K971100 · Atrion Medical Products, Inc. · EIA · May 23, 1997 · Dental

Device Facts

• Record ID: K971100
• Device Name: ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR
• Applicant: Atrion Medical Products, Inc.
• Product Code: EIA · Dental
• Decision Date: May 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The Atrion Medical Autogenous Tissue Collector is useful in the collection of bone or other tissue for reconstruction, implants and repair procedures, for collection of tissue for pathological analysis and for retrieving root tips and precious metals.

Device Story

The Atrion Medical Autogenous Tissue Collector is a single-use device designed for use in dental or surgical settings to capture biological material or small objects during procedures. The device consists of a plastic housing, a screen, a gasket, a screen support, and an elastomer tube. It functions as a mechanical filter to trap bone, tissue, root tips, or precious metals from suction lines or irrigation fluids. The device is operated by clinicians during surgical or dental procedures. By collecting autogenous tissue, the device facilitates subsequent reconstruction, repair, or pathological analysis. It is provided sterile via gamma or E-Beam irradiation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use mechanical filter. Components: plastic housing, polymer screen, gasket, screen support, elastomer tube. Sterilization: gamma or E-Beam irradiation.

Indications for Use

Indicated for the collection of bone or other tissue for reconstruction, implants, and repair procedures; collection of tissue for pathological analysis; and retrieval of root tips and precious metals.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Predicate Devices

• SciTech Clearline® Filter (K930144)

Submission Summary (Full Text)

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Atrion Medical Products, Inc.
1426 Curt Francis Road
Post Office Box 564
Arab, AL 35016
Tel [phone]
K971100
MAY 23 1997
Atrion
Medical

11.
# SUMMARY OF SAFETY AND EFFECTIVENESS

Date of Preparation: March 24, 1997

Device Name: Atrion Medical Autogenous Tissue Collector

Common Name: Autogenous Tissue Collector

Classification Name: Component (or accessory) to a Dental Operative Unit per 21 CFR Section 872.6640

Manufacturer: Atrion Medical Products, Inc., 1426 Curt Francis Road, Arab, AL 35016

Contact: Mr. Dan Clark
Atrion Medical Products, Inc., 1426 Curt Francis Road
Arab, AL 35016
Telephone: [phone]
Fax: [phone]

Predicate: SciTech Clearline® Filter, K930144

Device Description: The Atrion Medical Autogenous Tissue Collector consists of a screen, a gasket, screen support, plastic cover and elastomer tube. The device is a single-use product, sterilized by gamma or E-Beam irradiation.

Intended Use: The Atrion Medical Autogenous Tissue Collector is useful in the collection of bone or other tissue for reconstruction, implants and repair procedures, for collection of tissue for pathological analysis and for retrieving root tips and precious metals.

Technological Characteristics: Both the Atrion Medical device and the predicate device consist of a plastic housing containing a polymer screen. The Atrion Medical device consists of a screen, gasket, screen support, elastomer tube and plastic housing while the predicate device consists of an acrylic cartridge housing containing a screen.

Summary of Safety Testing: Based on the 510(k) "Substantial Equivalence" decision-making process and the information provided herein, we conclude that the new device is substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 23 1997

Mr. Dan Clark
Vice President Regulatory and Quality
Atrion Medical Products, Incorporated
1426 Curt Francis Road
Arab, Alabama 35016

Re: K971100
Trade Name: Atrion Medical Autogenous Tissue Collector
Regulatory Class: I
Product Code: EIA
Dated: March 24, 1997
Received: March 26, 1997

Dear Mr. Clark:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Clark

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone].

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Not known at this time

Device Name: **Atrion Medical Autogenous Tissue Collector**

Indications For Use:

1. For collection of bone or other tissue for reconstruction, implants and repair procedures.
2. For collection of tissue for pathological analysis.
3. For retrieving root tips and precious metals.

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

Shirley R. P. (Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K47100
Prescription Use ☑ OR Over-The-Counter Use ☐

(Optional Format 1-2-96)
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