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 stabilized 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 disks, in a parallel configuration, that are connected by an internal, serrated post. The devices will be available in several sizes with disk diameters in the range of 10mm to 18mm to be used for varying cranial closure techniques. The implant devices will be manufactured from 6AI4V titanium alloy material.

AI/ML Overview

The provided text is a 510(k) summary for the Bioplate® ZIP™ Craniotomy Fixation System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving new safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets them in the way a clinical trial would.

Instead, the document focuses on:

Device Description and Intended Use: The Bioplate® ZIP™ Craniotomy Fixation System is described as consisting of two circular disks connected by an internal, serrated post, made from 6AI4V titanium alloy. Its intended use is to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
Predicate Devices: Several predicate devices are listed, including systems from Stryker Instruments, Synthes (USA), Walter Lorenz Surgical, Ikonos Corp., and Aesculap, Inc., as well as a previous Bioplate® ZIP™ system (K013050).
Substantial Equivalence: The core argument of the 510(k) is that the new system has the "same indications for use as the predicate devices" and that "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."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided 510(k) summary. The FDA's letter explicitly states that they "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This implies a comparison to existing devices rather than a de novo clinical study to meet predefined acceptance criteria for novel safety or efficacy claims.

Summary

{0}------------------------------------------------

K020088 p'/3

FEB 0 8 2002

BIOPLATE, INC. 6911 Melrose Ave. Los Angeles, California 90038 Tel: (323) 549-9500, FAX: (323) 935-0110

Summary of Safety and Effectiveness

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

Bioplate, Inc. 6911 Melrose Avenue Los Angeles, CA 90038 (323) 549-9500 (323) 935-0110 (fax)

Carol E. Jones Contact Person:

Trade Name of Device

The Bioplate® ZIP™ Craniotomy Fixation System

Common name

Plate, Cranioplasty, Preformed, Non-Alterable

Classification name

Plate, Cranioplasty, Preformed, Non-Alterable

Device Classification

84GXN (21CFR - 882.5330)

Predicate Devices

Stryker Instruments (1) Leibinger Quik Disk K993990
- (2) Synthes (USA) Synthes Cranial Flap Twist Clamp K991860

{1}------------------------------------------------

Synthes (USA) (3) Synthes Cranial Flap Tube Clamp K992000

Walter Lorenz Surgical (4) Rapidflap Cranial Clamp K991029
Ikonos Corp. (5) Sevrain Cranial Clamp K971252
(6) Ikonos Corp. Sevrain Cranial Clamp SCC-200 Series K971408
Aesculap, Inc. (7) Aesculap Craniofix Titanium Clamp System K972332
Bioplate, Inc. (8) The Bioplate® ZIP™ Craniotomy Fixation System K013050

Description of the device

Intended used of the device

The Bioplate® ZIP™ Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

{2}------------------------------------------------

KO200W P³/₃

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

The Bioplate® ZIP™ Craniotomy Fixation System has the same indications for use as the predicate devices marketed by Bioplate, Inc., Synthes (USA), Stryker Instruments, Walter Lorenz Surgical, and Aesculap, Inc. All of the technical characteristics of The Bioplate® ZIP™ Craniotomy Fixation System are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 FEB

Ms. Carol E. Jones Bioplate, Inc. 6911 Melrose Avenue Los Angeles, California 90038-3305

Re: K020088

Trade Name: Bioplate® ZIP™ Craniotomy Fixation System Regulatory Number: 21 CFR 882.5330 Regulation Name: Performed Nonalterable Cranioplasty Plate Regulatory Class: II Product Code: GXN Dated: January 8, 2002 Received: January 10, 2002

Dear Ms. Jones:

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 ﺎﻧﻚ ﻣ laws or regulations.

{4}------------------------------------------------

Page 2 - Ms. Carol Jones

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) 594-4659. 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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Mark A. Milkusen

Celia M. Witten, Ph.D., M.D. Director Division of General Restorative And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 1 of 1

APPLICANT: Bioplate Inc.

510(k) NUMBER: (if known): K020088

Bioplate® ZIP™ Craniotomy Fixation System DEVICE NAME:

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109)

Over-The-Counter-

(Optional Format 1-2-96)

for Mark H. Mckinven

(Division Sign-Off) Division of General, Restorati & and Neurological Devices

510(k) Number _

KO20088

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).