(90 days)
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 on the site is achieved. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
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 6Al4V titanium allov material.
This looks like a 510(k) premarket notification for a medical device called "The Bioplate® ZIP™ Craniotomy Fixation System." This document primarily focuses on demonstrating substantial equivalence to predicate devices, not on a clinical study proving that the device meets specific performance acceptance criteria through quantitative metrics like accuracy, sensitivity, or specificity.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of regulatory submission. This document aims to show that the new device is as safe and effective as devices already on the market, rather than conducting a de novo performance study with specific statistical endpoints typically found in AI/diagnostic device submissions.
Here's a breakdown of the information that can be extracted from the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a quantitative, metric-based manner. For a 510(k) for a mechanical implant, the "acceptance criteria" usually revolve around demonstrating that the device has similar technological characteristics, intended use, and performs at least as well as predicate devices, without raising new safety or effectiveness concerns. This is qualitative rather than quantitative.
- Reported Device Performance: The document states: "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." This is the core "performance" claim for a 510(k), asserting equivalence. No specific quantitative performance metrics (e.g., tensile strength, fatigue life with specific values) are provided in this summary. Such data would typically be in supporting documentation that isn't part of this public summary.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document does not describe a test set or data provenance in the context of a performance study with human or image data. It pertains to a physical implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in this context, does not refer to expert-derived medical interpretations. It refers to engineering specifications and clinical outcomes related to surgical implants, which are assessed through engineering tests and clinical experience, not typical "expert consensus" on diagnostic data.
4. Adjudication method for the test set:
- Not Applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a hardware implant, not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this type of device, "ground truth" would be established through:
- Engineering specifications and standards: Confirming material properties, dimensions, and mechanical performance (e.g., strength, biocompatibility) against established standards for medical implants.
- Clinical experience with predicate devices: Relying on the long-standing safe and effective use of similar devices.
- Pre-clinical testing: Biocompatibility testing, potentially some in-vitro mechanical testing.
- The document implies that the "ground truth" is that the predicate devices are safe and effective, and the new device shares sufficient characteristics not to raise new concerns.
8. The sample size for the training set:
- Not Applicable. No training set as this is not a machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable.
In summary, based only on the provided text, a detailed response to your questions regarding acceptance criteria and performance studies in the context of diagnostic/AI devices cannot be fully generated because this document is a 510(k) summary for a physical medical implant, which follows a different regulatory pathway and relies on different types of evidence (primarily substantial equivalence to predicate devices and engineering/biocompatibility testing) rather than a clinical performance study with statistical endpoints for diagnostic accuracy.
The core "proof" in this document is the assertion of substantial equivalence to already legally marketed devices, as stated in the letter from the FDA: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..."
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K013050
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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
- (3) Synthes (USA) Synthes Cranial Flap Tube Clamp K992000
- Walter Lorenz Surgical (4) Rapidflap Cranial Clamp K991029
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- (5) Ikonos Corp. Sevrain Cranial Clamp K971252
- Ikonos Corp. (6) Sevrain Cranial Clamp SCC-200 Series K971408
- (7) Aesculap, Inc. Aesculap Craniofix Titanium Clamp System K972332
Description of the device
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 6Al4V titanium allov material.
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.
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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carol E. Jones Bioplate, Inc. 6911 Melrose Avenue Los Angeles, California 90038
Re: K013050
Trade/Device Name: The Bioplate® ZIP™ Craniotomy Fixation System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: September 11, 2001 Received: September 11, 2001
Dear Ms. Jones:
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. Jones
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to ocg... mainting of substantial equivalence of your device to a legally premits to the are in the President of the 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 II you desire specific advice for you invitro diagnostic devices), please contact the Office of additionally 21 CFR Far 007.10 Additionally, for questions on the promotion and advertising of Complance at (301) 591-1697 - 1697 - 1697 - 1639. Also, please note the your do roos, pread connect as a reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mionmation currers, 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,
Susan Walker,
Image /page/3/Picture/5 description: The image shows a handwritten letter 'fa' in cursive. The letter is written in black ink on a white background. The 'f' is slightly larger than the 'a', and the two letters are connected.
Celia M. Witten, Ph.D., M.D. Director Divison of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Bioplate Inc. APPLICANT:
510(k) NUMBER: (if known): KO(3050
DEVICE NAME: Bioplate® ZIP™ Craniotomy Fixation System
INDICATIONS FOR USE:
The Bioplate® ZIP™ Craniotomy Fixation System is intended to reattach a cranial The Bloplate® ZIP™ Cranium after a craniotomy procedure. The device is bone flap to the surrounding crailian and mealing proceacer. Fach device is
used to align and stabilized bony tissue while normal healing on the stire is used to align and stablized borly tissue while normal houling over and titanium alloy implants.
(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)
OR
Over-The-Counter-
(Optional Format 1-2-96)
Susan Walker/
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013050
§ 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).