(58 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. The "Not Found" entries for AI/ML-related terms further support this.
No
The device is used for the collection of tissue for reconstruction, implants, repair procedures, pathological analysis, and retrieving root tips and precious metals, but it does not treat or cure any condition itself.
No
The device is described as collecting bone or other tissue for reconstruction, implants, repair procedures, pathological analysis, and retrieving root tips and precious metals, none of which are diagnostic functions.
No
The device description explicitly lists physical components (screen, gasket, screen support, plastic cover, elastomer tube) and states it is a single-use product sterilized by irradiation, indicating it is a hardware device.
Based on the provided information, the Atrion Medical Autogenous Tissue Collector is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of bone or other tissue for reconstruction, implants, repair procedures, pathological analysis, and retrieving root tips and precious metals. While it mentions collection for pathological analysis, the device itself is for the collection of the sample, not for performing a diagnostic test on the sample.
- Device Description: The description details a physical device for collecting tissue, not a reagent, instrument, or system used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device performing any kind of test, analysis, or measurement on the collected tissue to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to diagnose diseases or other conditions. The Atrion Medical Autogenous Tissue Collector is a tool for collecting the specimen, which might then be used in an IVD process, but the collector itself is not the diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
EIA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
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.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel 205 586 1580
t
MAY 2 3 1997
K97110)
Image /page/0/Picture/2 description: The image shows the logo for Atrion Medical. The logo is black and consists of the word "Atrion" in a bold, sans-serif font, with a stylized swoosh extending from the left side of the "A". Below "Atrion" and slightly to the right, the word "Medical" is written in a smaller, sans-serif font.
| 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: (250) 586-1580 | |
| Fax: (205) 586-5553 | |
| 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. | |
| 000035 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, representing the department's focus on people and health.
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
K971100 Re : Atrion Medical Autogenous Tissue Collector Trade Name: Requlatory Class: I Product Code: EIA March 24, 1997 Dated: 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 anv 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.
2
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
Timo A. Ulatowski Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): Not known at this time
Device Name: Atrion Medical Autogenous Tissue Collector
Indications For Use:
- For collection of bone or other tissue for reconstruction, implants and repair procedures. 1.
- For collection of tissue for pathological analysis. 2.
- For retrieving root tips and precious metals. 3.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Situary Duranti |
|---|
| ----------------- |
| Submit | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| 510(k) Number | K971169 |
| Prescription Use (Per 21 CFR 801.109) | ✓ OR Over-The- Counter Use ______ |
(Optional Format 1-2-96) 000037