This product is mended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive osteolority and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular microgradhia. The device is monded to provide temporary stubilization and gradual lengthening of the crawial, midfacial, or mandibular bones.

Device Description

This device is a distraction system consisting of the following major components; distractor frame, extension rods, connector forks, distraction port or flexible shaft and distraction key. Depending on the frame is connected to either a distraction port or a flexible shaft, which is covered with a protective sheath.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the Guerrero - Bell Distractor meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Metric)	Reported Device Performance (Guerrero - Bell Distractor)	Related Predicate Device(s) for Comparison
Frame Stiffness (Static Cantilever Bend Test)	Significantly greater than	MULTI-GUIDE™ distractor
	Significantly greater than	Vazquez-Diner Distractor
Yield Strength (Static Cantilever Bend Test)	Significantly greater than	MULTI-GUIDE™ distractor
	Lower than	Vazquez-Diner Distractor

Note on Yield Strength: The submission explicitly states, "It is not anticipated that this difference will have any relevance in the clinical setting because of the low forces observed in patients who are treated with all of these devices." This implies that even though the yield strength was lower than one of the predicates, it still met an implicit (but not explicitly stated as a numerical threshold) clinical relevance criterion.

2. Sample Size Used for the Test Set and Data Provenance

The provided text describes in vitro mechanical testing, not a clinical study involving human or animal subjects. Therefore, the concept of "test set" in terms of patient data or clinical samples (and associated provenance) is not directly applicable.

Test Set: Multiple instances of the Guerrero - Bell Distractor, Vazquez-Diner Distractor, and MULTI-GUIDE™ distractor were used for the static cantilever bend testing. The exact number of devices tested for each model is not specified, but the use of "average yield strength" implies multiple samples.
Data Provenance: Not applicable as it's mechanical in vitro testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for mechanical testing is established by engineering standards and measurement accuracy, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to clinical studies where ambiguity in observation or diagnosis requires external review. For mechanical testing, the results are directly measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is a clinical study involving multiple human readers interpreting medical images or data. The study described is mechanical in vitro testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a conceptual sense. The testing performed on the device was "standalone" in that it assessed the mechanical properties of the device itself, without human interaction influencing its performance during the test (other than setting up the experiment). This is not an AI algorithm, so the "algorithm only" part is not relevant.

7. The Type of Ground Truth Used

The ground truth used for this study was objective mechanical measurements (e.g., force, displacement) obtained through standardized engineering testing (static cantilever bend testing).

8. The Sample Size for the Training Set

Not applicable. This refers to the data used to train an AI algorithm. The described study is mechanical testing of a medical device, not an AI product.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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K472166
AUS. 11,19

510(k) SUMMARY

Device Proprietary Name:	Guerrero - Bell Distractor
Device Common Name:	Bone Distractor
Classification Name:	Smooth or Threaded Metallic Bone FixationFastener 21 CFR 888.3040
Name of Submitter:	Howmedica Leibinger Inc.
Contact Person:	John F. DichiaraGroup Regulatory Affairs ManagerHowmedica Leibinger Inc.359 Veterans BlvdRutherford, NJ 07070Telephone: 201-507-7836Facsimile: 201-507-6870

Date Prepared:

6/6/97

Summary:

This submission describes a bone distraction system intended for use in the treatment of cranial, midfacial, or mandibular conditions for which reconstructive osteotomy and segment are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular micrognathia. The device is intended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones. This device is a distraction system consisting of the following major components; distractor frame, extension rods, connector forks, distraction port or flexible shaft and distraction key. Depending on the frame is connected to either a distraction port or a flexible shaft, which is covered with a protective sheath.

Static cantilever bend testing was conducted on the Guerrero and two currently available and legally marketed distraction devices, the Vazquez-Diner Distractor and the MULTI-GUIDE™ distractor (a.k.a. the Howmedica Mandibular Bone Distractor II). The results of the testing demonstrated that the Guerrero - Bell Distractor had a significantly greater frame stiffness compared to the MULTI-GUIDE™ and Vazquez-Diner devices. The Guerrero - Bell Distractor had an average yield strength which was significantly greater than the average vield strength of the MULTI-GUIDE™ device, and was lower than the Vazquez-Diner device. It is not anticipated that this difference will have any relevance in the clinical setting because of the low forces observed in patients who are treated with all of these devices.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Vazquez - Diner Intractor (Howmedica Leibinger K964649); the Mandibular Bone Distractor II (Howmedica K960297); the Normed Distractor (Ace Surgical Supply(US Distributor) K # Unknown); the Luhr Small Fixation Plating System (Howmedica K950595) and the Synthes Midface Plating System (Synthes) K953806.

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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 features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John F. Dichiara Group Regulatory Affairs Manager Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford. New Jersey 07070-2584

AUG 1 | 1997

Re: K972154 K972166 Trade Names: Cohen Distractor Guerrero-Bell Distractor Regulatory Class: II Product Code: JEY Dated: June 6, 1997 Received: June 9, 1997
Dear Mr. Dichiara:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements , as set forth in the Quality System Regulation (OS) 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification

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Page 2 - Mr. John F. Dichiara

submissions 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 laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Radiological Health

Enclosure

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FUL Job 19

Indications for Use

510(k) Number (if known): K972166

Devicu Naine

1 eibinger Guerrero-Bell Distractor

Indications for Use.

(PLEASE DO NOT WRITE BFLOW THIS LINE - CUNTINUE ON ANOTHER PAGE IF NULUDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

Prescription Use
X
(Per 21 CFR 801 109)

Over-The-Counter Use __

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.