The Bioplate® ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

Device Description

The Bioplate® ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques.

AI/ML Overview

This document describes the Bioplate® ZIP® Craniotomy Fixation System and its substantial equivalence to predicate devices, focusing on regulatory approval rather than a detailed performance study with acceptance criteria. As such, most of the requested information regarding acceptance criteria, study details, sample sizes, and expert adjudication for a device performance study is not available in the provided text.

The text primarily covers:

Device identification and classification
Intended use
Comparison to predicate devices, stating "All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy."
FDA's 510(k) clearance, indicating substantial equivalence to legally marketed predicate devices without requiring a full clinical performance study with specific acceptance criteria.

Therefore, many parts of your request cannot be fulfilled based on the provided input.

Here is the information that can be extracted or deduced:

Category	Description
1. Acceptance Criteria and Reported Device Performance	Not explicitly stated. The document asserts "substantial equivalence" to predicate devices K013050 and K020088. This implies that the device meets the same performance standards as the predicates, but no specific quantitative acceptance criteria (e.g., in terms of strength, fixation stability, biocompatibility, etc.) or corresponding reported performance values are provided within this text.
2. Sample size and Data Provenance (test set)	Not applicable / Not provided. The 510(k) submission primarily relies on a comparison to predicate devices, not on a new clinical study with a test set that would have a sample size or data provenance.
3. Number and Qualifications of Experts (test set)	Not applicable / Not provided. Ground truth for a test set based on expert opinion is not described.
4. Adjudication Method (test set)	Not applicable / Not provided. No adjudication method for a test set is described.
5. MRMC Comparative Effectiveness Study	No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned.
6. Standalone Performance Study	No. A standalone algorithm-only performance study with human-in-the-loop performance is not mentioned, as this is a physical medical device, not an AI/software device.
7. Type of Ground Truth Used	Not applicable / Not provided. For the 510(k) clearance, the "ground truth" is inferred from the established performance and safety of the legally marketed predicate devices. No specific pathology, outcomes data, or expert consensus serving as ground truth for a new performance study of this specific device's clinical efficacy is detailed.
8. Sample Size for Training Set	Not applicable / Not provided. As this is not an AI/ML device, there are no training sets or associated sample sizes in the context of an algorithm.
9. Ground Truth for Training Set	Not applicable / Not provided. No training set ground truth is established for this type of device.

Summary

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VI. Summary of Safety and Effectiveness

Submitter's name, address, telephone number and contact person:

Bioplate, Inc. 3643 Lenawee Avenue Los Angeles, CA, 90016 (310) 815-2100 (310) 815-2126 (fax)

Contact Person: Jesus Farinas

Trade name of Device:

Modified design of the Bioplate® ZIP® Craniotomy Fixation System. (K013050, K020088)

Common Name:

Plate, Cranioplasty, Preformed, Non-Alterable

Device Classification:

Class 2, 21 CFR 882.5330 GXN

Predicate Devices:

(1.) Bioplate, Inc. The Bioplate® ZIP® Craniotomy Fixation System (K013050)

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(2) Bioplate, Inc.
Device Modification of the Bioplate® ZIP® Craniotomy Fixation System (K020088)

Description of the Device:

Intended Use of the Device:

Comparison of the device's technological characteristics with those of the predicate devices

All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.

K070901 6/15/07.A

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bioplate, Inc. % Mr. Jesus T. Farinas Director, QA/RA 3643 Lenawee Avenue Los Angeles, California 90016-4310

JUN 1 5 2007

Re: K070901

Trade/Device Name: Bioplate® Zip® Craniotomy Fixation System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: II Product Code: GXN Dated: May 17, 2007 Received: May 18, 2007

Dear Mr. Farinas:

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 - Mr. Jesus T. Farinas

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (301) 443-6597 or on the Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Barbara Breen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):____ K070901

Device Name: Modified plate design for Bioplate® ZIP® Craniotomy Fixation System.

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Calvare Snelling

Division of General, Restorative, and Neurological Devices

510(k) Number K070901

Page 1 of

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).