(54 days)
Indications for use of the surgical bur and surgical drill bit devices are situations in surgical procedures where bone, hard tissue, or soft tissue is drilled, reamed, sculpted, augmented, reduced, replaced, or removed.
The subject devices (surgical burs and surgical drill bits) are stainless steel and/or tungsten carbide devices which may be coated with abrasion resistant coatings in order to increase cutting efficiency. They will be supplied as both sterile and non-sterile devices and will be labeled for single use.
The provided text is a 510(k) summary for surgical burs and surgical drill bits. It discusses the device's description, intended use, and substantial equivalence to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
Specifically, the document states: "Safety and Effectiveness Testing: All materials used in the surgical bur and surgical drill bit devices conform with industry specifications for medical device use. Material specifications are tested on a design basis." This indicates that safety and effectiveness were assessed through material specification conformity and design-based testing, but it does not provide any quantitative results, specific acceptance criteria, or details of a study that would allow for the completion of the requested table and sections.
Therefore, I cannot provide the requested information from the given text.
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AUG 26 1997
ATTACHMENT 8
510(k) SUMMARY
SYNVASIVE Technology, Inc. Submitting Company: 4925 Robert J. Matthews Pkwy. El Dorado Hills, CA 95762
916-939-3913 Telephone:
916-939-3919 Fax :
t
Contact Person: Michael G. Fisher President and CEO
June 13, 1997 Date Prepared:
Surgical Burs and Surgical Drill Bits Common Product Name:
Surgical Instrument Motors and Classification Name: Accessories/Attachments (per 21 CFR 878.4820)
The subject devices (surgical burs and Product Description: surgical drill bits) are stainless steel and/or tungsten carbide devices which may be coated with abrasion resistant coatings in order to increase cutting efficiency. They will be supplied as both sterile and non-sterile devices and will be labeled for single use.
The surgical bur and surgical drill bit devices are Intended Use: for use during surgical procedures to cut hard tissue or bone and soft tissue.
Substantial Equivalence: The surgical bur and surgical drill bit devices are substantially equivalent to standard surgical burs and surgical drill bits legally marketed by many companies including DePuy, MicroAire, Synthes, and Zimmer.
The surgical bur and surgical drill Technological Characteristics: bit devices have the same technological characteristics as all of the predicate devices.
Safety and Effectiveness Testing: All materials used in the surgical bur and surgical drill bit devices conform with industry specifications for medical device use. Material specifications are tested on a design basis.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Fisher President and CEO SYNVASIVE Technology, Inc. 4925 Robert J. Matthews Parkway El Dorado Hills, California 95762
AUG 26 1997
Re: K972508
Trade Name: Surgical Burs and Surgical Drill Bits Regulatory Class: I Product Code: HWE Dated: June 13, 1997 Received: July 3, 1997
Dear Mr. Fisher:
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 requirements . 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
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Page 2 - Mr. Michael Fisher
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
Celia M. Witten, Ph.D., M.D.
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
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ATTACHMENT 9
INDICATION FOR USE STATEMENT
510 (k) Number:
Device Name:__________________________________________________________________________________________________________________________________________________________________ CFR 878.4820, Surgical Instrument Motors and Accessories/Attachments
Indications for Use: Indications for use of the surgical bur and surgical drill bit devices are situations in surgical procedures where bone, hard tissue, or soft tissue is drilled, reamed, sculpted, augmented, reduced, replaced, or removed.
Concurrence of CDRH, Office of Device Evaluations (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
SYNVASIVE Technology, Inc
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | Page 41 |
| 510(k) Number | K972508 |
§ 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.