(82 days)
No
The description focuses on a mechanical bone collection system using a filter and suction, with no mention of AI or ML.
No.
The device is described as a collection system for autogenous bone particles for use in augmentation procedures, not as a device that delivers therapy itself.
No
Explanation: The device is designed to collect bone particles during surgery, not to diagnose a condition or disease. Its purpose is to facilitate augmentation procedures by providing collected bone.
No
The device description clearly outlines a physical "housing and filter apparatus" and "filter cartridge" which are hardware components used to collect bone particles. It is not solely software.
Based on the provided information, the IMTEC Bone Collector System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- IMTEC Bone Collector System Function: The IMTEC Bone Collector System is a device used during surgery to collect bone particles directly from the patient's body. It is a surgical tool designed to facilitate the collection of autogenous bone for use in augmentation procedures. It does not perform any tests on samples taken from the body.
The device's function is to physically collect material during a surgical procedure, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The IMTEC Bone Collector System is designed to facilitate the collection of autogenous bone particles for use in augmentation procedures. This is accomplished by introducing into the surgical suction line a housing and filter apparatus. Autogenous bone particles which would otherwise be loss into the suction system are trapped in this filter. This material may be easily retrieved for usage.
Product codes
EZH
Device Description
The IMTEC Bone Collector System is designed to facilitate the collection of autogeneous bone for use in augmentation procedures. Adapted from an oral suction device it contains a filter cartridge which traps bone particles resulting from drilling into bone. The filter can be removed and the bone particles asceptically collected. The filters are available either sterile/single use or autoclavable. The autoclavable filter cartridge is not recommended for reuse in bone collection augmentation procedures.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510 (k) Summary
SUBMITTED BY:
M. K. Patterson, Jr. PhD Sr. Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401 (405) 223-4456
F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407
Date Submitted: September 1, 1997
CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:
Classification Name: Non-powered, portable suction apparatus. Common/ Usual Name: Suction Powered Oral Cavity Evacuator. Proprietary Name: IMTEC Bone Collector System.
PREDICATE DEVICE:
ODONTIT, The ODONTIT Autogeneous Bone Collection Device, K971036.
DEVICE DESCRIPTION:
The IMTEC Bone Collector System is designed to facilitate the collection of autogeneous bone for use in augmentation procedures. Adapted from an oral suction device it contains a filter cartridge which traps bone particles resulting from drilling into bone. The filter can be removed and the bone particles asceptically collected. The filters are available either sterile/single use or autoclavable. The autoclavable filter cartridge is not recommended for reuse in bone collection augmentation procedures.
1
INDICATIONS FOR USE:
The IMTEC Bone Collector System is designed to facilitate the collection of autogenous bone particles for use in augmentation procedures. This is accomplished by introducing into the surgical suction line a housing and filter apparatus. Autogenous bone particles which would otherwise be loss into the suction system are trapped in this filter. This material may be easily retrieved for usage.
PRINCIPLES OF OPERATION:
The IMTEC Bone Collection utilizes an oral suction device to asceptically trap particulate autogenous bone, which can be used as unadulterated bone filling material or as a mixture with other natural or synthetic filling materials.
CONTRAINDICATIONS:
Contraindications customary to the use of bone grafting materials should be observed. These include but are not limited to, current local infection, vascular impairment at the surgical site, uncontrolled diabetes, chronic high dose steroid therapy, clotting disorders, current anticoagulant therapy, metabolic bone disease, and other metabolic or systemic disorders which affect bone or wound healing.
COMPLICATIONS:
Possible complications with any oral reconstructive surgery include infection, closure perforation, abscess formation, bone loss, pain, soft tissue irregularities, and additional complications associated with anesthesia and dental surgery. There should be few specific complications resulting from the use of autogeneous bone.
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MATERIALS OF CONSTRUCTION:
| Bone Collector Housing | Aluminum 6061 |
|---|---|
| Filter Cartridge, Sterile | |
| Screen | 150 micron Polyester |
| Support material | ABS Lustran 248-2002 |
| Filter Cartridge, Autoclavable | |
| Screen | 150 micron Polyster |
| Support material | Polypropylene |
| O-Rings | Nitrile, Hydrogenated |
WARNING:
Surgical techniques required for bone augmentation procedures are highly specialized and complex. Specialized training is strongly recommended. Practitioners should attend courses of study to prepare them in established techniques. Improper technique can cause graft failure or loss of bone.
PRECAUTIONS:
Aseptic Technique required. Establish the location of all anatomical features to be avoided prior to initiating any dental surgical procedure.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a licensed dentist or physician, and use by any other person is prohibited.
For technical assistance, and more information or to order please call our toll free number: (800) 879-9799 or (405) 223-4456. The address is as follows:
IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401
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... .. . . .
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized representation of a human figure, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1997
!
M.K. Patterson, Jr. Ph.D. ·Sr. Vice President Requlatory Affairs IMTEC Corporation 2401 North Commerce P.O. Box 1562 Ardmore, Oklahoma 73401
K973248 Re : Imtec Bone Collector System Trade Name: Regulatory Class: I Product Code: EZH Dated: August 29, 1997 Received: August 29, 1997
Dear Dr. Patterson:
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, 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Patterson
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 diagnostic 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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 (301) 443-6597 or at its internet address "http://www.ffa.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
. Enclosure
5
510(k) Number (if known):
510(k) Number (if known): K973248
IMTEC BONE COLLECTOR SYSTEM Device Name:
Indications For Use:
The IMTEC Bone Collector System is designed to facilitate the collection of autogenous bone particles for use in augmentation procedures. This is accomplished by introducing into the surgical suction line a housing and filter apparatus. Autogenous bone particles which would otherwise be loss into the suction system are trapped in this filter. This material may be easily retrieved for usage.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Herald Shepps |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K973248 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)