(197 days)
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No
The description focuses on mechanical tools (trephines and drills) and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is used to obtain and insert a bone graft for the treatment of avascular necrosis, directly addressing a medical condition.
No
The device is used to obtain and insert a bone graft for treatment of Avascular necrosis. It is a surgical tool, not a diagnostic one.
No
The device description explicitly states it comprises "a series of trephines and purchased canulated drill bits," which are physical surgical instruments, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The AV Core System is described as a system of trephines and drills used to obtain and insert a bone graft into the femoral head. This is a surgical procedure performed on the body, not a test performed on a specimen taken from the body.
- Intended Use: The intended use is for treating avascular necrosis of the femoral head by obtaining and inserting a bone graft. This is a therapeutic intervention, not a diagnostic test.
- Regulation Number and Product Code: The provided regulation number (882:4305) and product code (84HBF) are associated with surgical instruments, specifically drills, burs, and trephines, which are not IVDs.
Therefore, based on the provided information, the AV Core System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AV Core System is a system of cannulated trephines and drills used to obtain and insert a contoured bone graft into a matched hole in the femoral head. The use of the system is indicated for patients suffering from Avascular Necrosis, in which the head does not collapse or degenerative changes.
Product codes (comma separated list FDA assigned to the subject device)
84HBF, HWE
Device Description
The AvCore System comprises of a series of trephines and purchased canulated drill bits of matched size, used to obtain a appropriate sized and contoured bone graft in the treatment of avascular necrosis of the femoral head.. The device is classified under the nomenclature of drills, burs, Trephines & accessories ( compound, powered). Trephines of various types were originally utilized for performing burr holes into the skull since the days of the cave man. Modern trephines of stainless steel are still utilized in orthopedic and neurosurgery for obtaining cylindrical bone grafts and for removal of broken hardware. All of these devices including many made prior to 1976 are essentially equivalent to the cores described in this application as they are all hollow cylinders of hard stainless steel with teeth machined into their front end and shanks at the rear to be placed in a drill chuck. They are turned in a rotary fashion to obtain the circular grafts and all are sterilized by use of the steam autoclave. In the AvCore system the bone grafts are obtained from the base of the trochanter with the trephines and the matched drills used to remove the avascular area. The shaft of the AvCoreTrephines can be unlocked and be moved forward to act as an ejector for the graft material. No instrument is supplied as sterile and all instruments can be steam sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Femoral head, hip, cervical, knee, wrist
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
SEP 2 4 1999
Modular Cutting Systems
650 Clinton Avenue Bridgeport, CT 06605
Phone (203) 335-1844 Fax Fax Fax (203) 335-2968
K 990816
ALLEN P. SCHLEIN M.D.
February 28, 1999
510 (K) Summary
AvCore System
The AvCore System comprises of a series of trephines and purchased canulated drill bits of matched size, used to obtain a appropriate sized and contoured bone graft in the treatment of avascular necrosis of the femoral head.. The device is classified under the nomenclature of drills, burs, Trephines & accessories ( compound, powered). The product code is 84HBF and regulation number 882:4305 and is a Class II device.
Trephines of various types were originally utilized for performing burr holes into the skull since the days of the cave man. Modern trephines of stainless steel are still utilized in orthopedic and neurosurgery for obtaining cylindrical bone grafts and for removal of broken hardware. All of these devices including many made prior to 1976 are essentially equivalent to the cores described in this application as they are all hollow cylinders of hard stainless steel with teeth machined into their front end and shanks at the rear to be placed in a drill chuck. They are turned in a rotary fashion to obtain the circular grafts and all are sterilized by use of the steam autoclave.
In treating Avascular Necrosis of the femoral head, Ponseti reported on the use of trephines to remove the lesion for biopsy in The Journal of Bone and Joint Surgery 31-A 1949 and a similar report was written by Bonfiglio and Bardenstein in The Journal of Bone and Joint Surgery 52-A:322 1970.
The trephines used by these authors are essentially the same as those in the AvCore System. The only difference in technique is that these authors used the trephines to remove the avascular area and then used a fibular or tibial bone graft in the formed channel. In the AvCore system the bone grafts are obtained from the base of the trochanter with the trephines and the matched drills used to remove the avascular area. The shaft of the AvCoreTrephines can be unlocked and be moved forward to act as an ejector for the graft material.
Substantial equivalance is claimed to the trephines manufactured by Gambale & Merrill in the performance of cranial flaps. The trephines in the Cloward System for obtaining bone grafts for cervical fusion and the Codman Anterior Cervical Fusion Kit are also similar to those used in the
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1
AvCore System. A trephine was also part of the instrumentation utilized to insert the stem of the St. George- Buchholz knee. The above devices, I believe were marketed in the U.S.A. prior to 1976.
Trephines have been manufactured by DePuy Corporation, Warsaw, Indiana as screw removal instruments. The CORB Biopsy System manufactured by Zimmer Inc., Warsaw Indiana utilized powered trephines used for removal of avascular segments of the femoral head.
Trephines are presently marketed by Arthrex Inc., Naples Florida and Smith & Nephew. Andover, Massachusetts for obtaining and implantation of articular osteochondral grafts of the knee. Trephines are also used for the harvesting of knee ligament grafts and in obtaining grafts for wrist fusion by Roberts Medical, Inc. Boyertown, Pennsylvania.
Catalogue pages or advertisements are supplied for the items we feel are of substantial equivilance.
The Surgical Technique for the instruments supplied as the AvCore System is also supplied in a separate section of this 510 (K) application.
Please note that all Avcore instruments are manufactured by a contract manufacturer, FDT Precision, Taunton, Massachusetts utilizing acceptable manufacturing principles and techniques. No instrument is supplied as sterile and all instruments can be steam sterilized.
No claims are to be made for the efficacy of the technique of core biopsy which has been discussed substantially in the orthopedic literature. The instruments in the AvCore system merely facilitate the manner in which the procedure is performed, as a secondary bone graft site is not required.
Based on the documentation that trephine instrumentation both existed and was used in the treatment of avascular necrosis of the hip and other areas prior to 1976, it is my feeling that the instruments should be considered exempt or at least substantially equivalent to trephines being manufactured and sold at the present time.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head and wings of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Allen P. Schlein, M.D. President Modular Cutting Systems, Inc. 650 Clinton Avenue Bridgeport, Connecticut 06605
Re: K990816 Trade Name: AvCore System Regulatory Class: I Product Code: HWE Dated: July 2, 1999 Received: July 8, 1999
Dear Dr. Schlein:
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 -- Allen P. Schlein, M.D.
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 (301) 594-4595. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Salie McWitter, Ph.D., M.P.H.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page of
510(k) Number (if known):
Device Name: AV Core System
Indications For Use:
The AV Core System is a system of cannulated trephines and drills The AV Core System IS a ByBeem of cannone graft into a matched hole used to obtain and insert a carrered benem is indicated for patients
in the femoral head. The use of the system is indicated done ret In the remoral head. The abe of the bylowhich the head does not Surrering from Avaoodian nooroma, collapse or degerative changes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K940816 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
O