(63 days)
Not Found
No
The summary describes a mechanical distraction system with no mention of AI or ML components or functions.
Yes
The device is described as being used in the "treatment of cranial, midface, or mandibular conditions" and is "intended to provide temporary stabilization and gradual lengthening" of bones, indicating its therapeutic purpose.
No
This device is described as a "distraction system" for "treatment" and "gradual lengthening" of bones, which indicates a therapeutic rather than diagnostic function.
No
The device description explicitly lists physical components such as a distractor frame, extension rods, connector forks, distraction port or flexible shaft, and a distraction key, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in the treatment of cranial, midface, or mandibular conditions. It's a surgical device for reconstructive osteology and segment advancement.
- Device Description: The description details a mechanical distraction system with components like frames, rods, and keys. This is consistent with a surgical implant or external fixation device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely mechanical and therapeutic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JEY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, midfacial, or mandibular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K964649, K960297, K # Unknown, K950595, K953806
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Fixation |
| Fastener 21 CFR 888.3040 | |
| Name of Submitter: | Howmedica Leibinger Inc. |
| Contact Person: | John F. Dichiara |
| Group Regulatory Affairs Manager | |
| Howmedica Leibinger Inc. | |
| 359 Veterans Blvd | |
| Rutherford, NJ 07070 | |
| Telephone: 201-507-7836 | |
| Facsimile: 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.
1
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
2
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
3
FUL Job 19
Indications for Use
510(k) Number (if known): K972166
Devicu Naine
1 eibinger Guerrero-Bell Distractor
Indications for Use.
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.
(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)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices