(85 days)
Synthes Rapid Resorbable Cranial Clamp is indicated for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations.
Synthes Rapid Resorbable Cranial Clamp consists of two disks connected by a tensioned ratcheting shaft. The clamps fit a range of burr holes and craniotomy gap sizes.
The provided text is a 510(k) summary for the Synthes Rapid Resorbable Cranial Clamp, which seeks to demonstrate substantial equivalence to previously marketed devices. This type of submission generally does not include detailed studies with acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies, as it's not a de novo device requiring extensive clinical validation for novel performance claims.
Instead, the submission focuses on mechanical and material properties that establish equivalence to predicate devices, and the document explicitly states: "Documentation was provided which demonstrated the Synthes Rapid Resorbable Cranial Clamp to be substantially equivalent to other legally marketed devices."
Therefore, I cannot extract the requested information from the provided text because it is not present in a 510(k) summary focused on substantial equivalence. The document doesn't describe a study with performance targets or acceptance criteria as one would find for a novel device making specific diagnostic performance claims.
If this were a device requiring such performance criteria, the information would typically be presented in a dedicated section on performance studies.
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510(k) Summary
3.0
SEP = 8 2004
K 041611
Page _________ of ____
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301(610) 647-9700 |
|---|---|
| Device Name: | Class II, §882.5250 - Burr hole coverClass II, §882.5360 - Cranioplasty plate fastener |
| Classification: | Title 21 CFR 882.5250: Burr Hole Cover and section 882.5360:Cranioplasty Plate Fastener. |
| Predicate Device: | Synthes Resorbable Cranial ClampBiomet Lactosorb RapidFlap |
| Device Description: | Synthes Rapid Resorbable Cranial Clamp consists of two disksconnected by a tensioned ratcheting shaft. The clamps fit a rangeof burr holes and craniotomy gap sizes. |
| Intended Use: | Synthes Rapid Resorbable Cranial Clamp is intended for coveringburr holes and for fixation of cranial bone flaps in adult andpediatric populations. |
| SubstantialEquivalence: | Documentation was provided which demonstrated the SynthesRapid Resorbable Cranial Clamp to be substantially equivalent toother legally marketed devices. |
| The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Federal Food, Drug and Cosmetic Act, as amendedand as applied under 21CFR 807, Subpart E under which a devicecan be marketed without premarket approval or reclassification. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest under theUS Patent Laws or their application by the courts. |
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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli. Pennsylvania 19301
Re: K041611
Trade/Device Name: Rapid Resorbable Cranial Clamp Regulation Number: 21 CFR 882.5250, 21 CFR 882.5360 Regulation Name: Burr hole cover, Cranioplasty plate fastener Regulatory Class: II Product Code: GXR, HBW Dated: June 14, 2004 Received: June 15, 2004
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and the FDA finding of substantial equivalence of your device to a legally promated 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), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Milken
Celia M. Witten, PhD, MD Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0
Indications for Use
(041611
Rapid Resorbable Cranial Clamp
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes Rapid Resorbable Cranial Clamp is indicated for covering burr holes and for fixation of cranial bone flaps in adult and pediatric populations.
Prescription Use
(Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
Jse
rt C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mulkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041611
§ 882.5250 Burr hole cover.
(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).