(113 days)
No
The description focuses on mechanical components and their function in bone distraction, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for use in the treatment of cranial conditions and provides temporary stabilization and gradual lengthening of cranial bones, which are therapeutic functions.
No
The device is described as a system for "gradual lengthening of the cranial bones" and "temporary stabilization and gradual lengthening of the cranial bones" by "bone elongation." This indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly details hardware components such as distractors, spacers, screws, and instrumentation made from titanium, stainless steel, aluminum, and plastic. There is no mention of software as a component of this system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for the mechanical treatment of cranial conditions by gradually lengthening bone. This is a direct intervention on the body, not a test performed on a sample taken from the body.
- Device Description: The description details implants (distractors, screws, spacers) and surgical instruments used for placement and activation. This aligns with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The OSTEOMED Cranial Distraction System intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OSTEOMED Cranial Distraction System is intended for single patient use only.
Product codes
PBJ
Device Description
The OsteoMed Cranial Distraction System is comprised of distractors, spacers, screws and instrumentation. The distractor is an internal distraction device for bone elongation of cranial bones. The distractor is anchored between the osteotomy with 1.2mm standard or 1.2mm AutoDrive screws previously cleared under K924138 and K023260, respectively. The distractor is activated using a distractor tool via the distraction rod. The distraction rod is preassembled within the distractor device. The non-threaded portion of the distractor rod can be removed during the consolidation period. The distractors, spacers, and screws are removed after consolidation.
The instruments include distractor tool, drills, plate bending forceps, plate cutters and screwdrivers to facilitate the placement of screws and modification of the distractor assembly plates. A distractor rod removal tool is also available to partially remove the distractor rod leaving the distracted device in place.
The distractor assembly is made from Titanium (ASTM F-67) and Titanium Allov (ASTM F-136), and the spacer is made from Titanium (ASTM F-67). The screws are made from Titanium Alloy (ASTM F-136). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial bones
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)
Verification testing consisted of mechanical testing and comparisons against the KLS predicate device. The OSTEOMED Cranial Distraction System performed equivalent as the KLS predicate device. Clinical testing is not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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K 12 1304
Image /page/0/Picture/1 description: The image shows the logo for Osteomed. The logo is in black and white and features the word "OSTEOMED" in a bold, sans-serif font. The word is enclosed in an oval shape. The logo has a modern and professional look.
510(k) Summary
AUG 222 2012
Submitter Information:
OsteoMed 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Contact Person:
Mrs. Piedad Peña
Date Prepared:
August 20, 2012
Device Information:
Proprietary/Trade Name: Common Name:
OsteoMed Cranial Distraction System Cranial Distraction System
Classification Name:
- · Regulation Number: 21 CFR 882.5330
- · Regulation Name: Preformed nonalterable cranioplasty plate
- · Product Code:
- PBJ o
Device Class: II
Predicate Devices:
KLS-Martin, K003883 Classification Name: Bone Plate (21CFR 872.4760, Product Code JEY) Device Class: II
Device Description:
The OsteoMed Cranial Distraction System is comprised of distractors, spacers, screws and instrumentation. The distractor is an internal distraction device for bone elongation of cranial bones. The distractor is anchored between the osteotomy with 1.2mm standard or 1.2mm AutoDrive screws previously cleared under K924138 and K023260, respectively. The distractor is activated using a distractor tool via the distraction rod. The distraction rod is preassembled within the distractor device. The non-threaded portion of the distractor rod can be removed during the consolidation period. The distractors, spacers, and screws are removed after consolidation.
The instruments include distractor tool, drills, plate bending forceps, plate cutters and screwdrivers to facilitate the placement of screws and modification of the distractor assembly plates. A distractor rod removal tool is also available to partially remove the distractor rod leaving the distracted device in place.
OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779
Image /page/0/Picture/25 description: The image shows a logo with the word "Colson" in a stylized font inside a circle. To the right of the circle, the text "A COLSON ASSOCIATE" is written in a smaller, sans-serif font. The logo appears to be for a company or organization named Colson and its associates.
1
Image /page/1/Picture/1 description: The image shows the logo for OsteoMed. The logo is in black and white and features the word "OsteoMed" in bold, sans-serif font. The word is enclosed in an oval shape with a black stripe above the word. The oval shape is outlined in black.
The distractor assembly is made from Titanium (ASTM F-67) and Titanium Allov (ASTM F-136), and the spacer is made from Titanium (ASTM F-67). The screws are made from Titanium Alloy (ASTM F-136). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
Intended Use:
The OSTEOMED Cranial Distraction System intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OSTEOMED Cranial Distraction System is intended for single patient use only.
Intended use is equivalent to the KLS and OsteoMed predicate devices.
Technological Characteristics:
The KLS predicate device is an internal distractor for bone elongation, which distracts via a threaded rod. OsteoMed internal distractor also uses a threaded rod for distraction and is anchored using bone screws. Both use a distraction tool for distraction.
Materials used for the distractor are the same as the predicate devices, Titanium/Titanium Alloy. These materials are biocompatible.
Performance / Clinical Data:
The OSTEOMED Cranial Distraction System performed equivalent as the KLS predicate device based on verification testing. Verification testing consisted of mechanical testing and comparisons against the KLS predicate device. The intended use if the device is the same as the KLS Predicate Device.
Clinical Testing is not required to support substantial equivalence.
In conclusion, the device is safe and effective and performs as well as the predicate device.
Substantial Equivalence:
The basis of substantial equivalence for this device is based on similarities in intended use, material, function, performance, sterilization design, technology and operational principle to the predicate device, KLS-Martin (K003883) Distraction System, based on their promotional materials, labeling and clearance letter.
Due to the similarity of materials and design to the predicate device, OsteoMed believes that the OsteoMed Cranial Distraction System does not raise any new safety or effectiveness issues.
OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OsteoMed c/o Mrs. Piedad Peña Sr. Regulatory Affairs Specialist 3885 Arapaho Road Addison, TX 75001
AUG 222 2012
Re: K121304
OsteoMed Cranial Distraction System Regulation Number: 21 CFR 885.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: PBJ Dated: July 29, 2012 Received: July 31, 2012
Dear Mrs. Peña:
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, Drig, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not maching.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 not in 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121304
Device Name: OsteoMed Cranial Distraction System
. Indications for Use:
The OsteoMed Cranial Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation.
The OsteoMed Cranial Distraction System implants are intended for single use only.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off,
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K121304