(428 days)
Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.
Aesculap's PEEK CranioFix consists of two absorbable discs connected by a suture loop.
Here's a breakdown of the acceptance criteria and study information for the Aesculap PEEK CranioFix, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific performance standards promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. | The device was evaluated and performs in accordance with ASTM F452/ASTM F2026. The subject device was found to be similar in performance to previously cleared spinal systems with similar indications. (Note: The provided text does not specify quantitative acceptance criteria (e.g., specific force, torque, or displacement values). The acceptance appears to be based on adherence to these ASTM standards and comparative performance to similar, cleared devices.) |
| Biocompatibility of materials for implants. | All materials used (PEEK) are well recognized in their use as being biocompatible materials for implants and have been used in surgical procedures for many years. These materials have been accepted in previously cleared submissions. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not contain any information regarding a "test set" in the context of clinical or image-based evaluations. The performance data section refers to engineering and material standards. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
As there is no mention of a "test set" involving expert review or clinical images, this information is not applicable and therefore not available.
4. Adjudication Method for the Test Set:
Given the type of device and the information provided, there was no "test set" and no adjudication method for a clinical or image-based evaluation. The evaluation was based on material properties and mechanical performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No information about a multi-reader multi-case (MRMC) comparative effectiveness study is present in the provided text. The device is a physical implant, not a diagnostic imaging AI tool.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study for an algorithm was conducted or reported, as this device is a physical craniofix and not an artificial intelligence algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is based on established engineering standards (ASTM F452/ASTM F2026) and comparison to the mechanical and biological performance of previously cleared devices/materials. It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic device.
8. Sample Size for the Training Set:
This information is not applicable as the device is not an AI algorithm requiring a training set. The "training" for the device refers to its design based on established engineering principles and material science, and the manufacturing processes.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not an AI algorithm with a "training set" in the computational sense. The "ground truth" for the device's development (if conceptualized that way) would be established through scientific understanding of material properties, biomechanics, and safety/efficacy requirements for similar medical implants, drawing upon extensive prior research and regulatory precedents for materials like PEEK and the predicate device.
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K091692
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
| Aesculap PEEK Craniofix |
|---|
| August 10, 2010 |
AUG 1 2 2010
Aesculap® Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714
Lisa M. Bovle CONTACT: 800-258-1946 (phone) 610-791-6882 (fax)
Aesculap PEEK CranioFix TRADE NAME:
Burr Hole Cover COMMON NAME:
CLASSIFICATION NAME: Cover, Burr, Hole (GXR)
REGULATION NUMBER: 882.5250
SUBSTANTIAL EQUIVALENCE
The Aesculap PEEK CranioFix as described in this premarket notification is substantially equivalent to the following predicate device:
- Aesculap Absorbable Craniofix (K040080)
DEVICE DESCRIPTION
ﺳﯿﺮ
Aesculap's PEEK CranioFix consists of two absorbable discs connected by a suture loop.
INDICATIONS FOR USE
Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}
The Aesculap PEEK Craniofix has similar characteristics in design features (size, shape, function) and is considered substantially equivalent to the previously cleared predicate device on the market (K040080). The only change to the new device when compared to the predicate is a change in material.
All materials used in the manufacturing of the PEEK Craniofix are well recognized in their use as being biocompatible materials for implants and have been used in surgical procedures for many years. These materials have been accepted in previously cleared submissions.
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091692
PERFORMANCE DATA
. . .
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. This device has been evaluated and performs in accordance with ASTM F452/ASTM F2026. The subject device was found to be similar in performance to previously cleared spinal systems with similar indications.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap®, Inc. c/o Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
AUG 1 2 2010
Re: K091692
Trade/Device Name: Aesculap PEEK CranioFix Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: June 14, 2010 Received: June 15, 2010
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, Or to 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 misbrandi, ing and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Lisa M. Boyle
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 af 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elections product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115800.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 305 Almin ase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR) Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofire no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kesia Alexander
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Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K091692 PEEK CranioFix
AUG 1 2 2010
INDICATIONS FOR USE STATEMENT A.
510(k) Number (if known): K091692
Device Name: PEEK CranioFix
Indication for Use:
Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.
Over-the-Counter Use Prescription Use or
(per 21 CFR 801.109)
(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 Ophthalmic, Neurological and Ear, Nose and Throat Devices
(Optional Format 3-10-98)
510(k) Number K091692
002
§ 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).