(127 days)
No
The device description focuses on the material composition and physical properties of a bone graft system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as an "OSS Bone Graft System" which is used to fill bony voids and defects, indicating a therapeutic purpose to aid in bone repair and regeneration.
No
This device is described as a bone graft system intended for filling bony voids, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a bone graft system packaged as powder and liquid components that are mixed to form a paste, indicating a physical, non-software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids in the skeletal system. This is a therapeutic or structural application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a bone graft material mixed and applied intraoperatively. This is a medical device used directly on a patient during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
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 OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.
Product codes
MQV
Device Description
OSS Bone Graft System and OSS RapidSet Bone Graft System are packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively to produce a homogenous paste that car be applied to bone gaps or defects. The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate. The liquid component is a solution comprised of anhydrous citric acid (C,H,O,) and distilled water (H₂O). When mixed, the powder and liquid combine to form a homogenous paste.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, spine and pelvis)
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)
Non-Clinical Testing: Non-clinical testing provided included elemental analysis, a determination of set time, X-ray diffraction analysis, determination of surface pH, and exothermic temperature.
Clinical Testing: None provided
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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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K04-1089
AUG 3 1 2004
BIOMET
510(k) Summary
Applicant/Sponsor:Biomet Manufacturing Corp. P.O. Box 587 Warsaw, IN 46581
Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist
Proprietary Name: OSS Bone Graft System and OSS RapidSet Bone Graft System
Common Name: Bone Graft Substitute
Classification Name: Resorbable calcium salt bone void filler device (21 CFR 888.3045)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The current product is identical to the material previously cleared through 510(k)s K990290, ourrent pland K023718 for craniofacial applications and K003494 for dental applications.
Products cleared for orthopedic applications include: α-BSM® Bone Substitute Material (K011048), Norian® SRS® Bone Void Filler (K011897) and Pro Osteon® 500R Resorbable Bone Graft Substitute (K990131).
Device Description: OSS Bone Graft System and OSS RapidSet Bone Graft System are packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively to produce a homogenous paste that car be applied to bone gaps or defects.
The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate. The liquid component is a solution comprised of anhydrous citric acid (C,H,O,) and distilled water (H₂O). When mixed, the powder and liquid combine to form a homogenous paste.
Intended Use: The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.
Image /page/0/Figure/14 description: The image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581 0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 16582. The office number is 574.267.6639, the fax number is 574.267.8137, and the email address is biomet@biomet.com.
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Summary of Technologies: The materials, design and processing OSS Bone Graft System and OSS RapidSet Bone Graft System are similar or identical to the predicate products.
Non-Clinical Testing: Non-clinical testing provided included elemental analysis, a determination of set time, X-ray diffraction analysis, determination of surface pH, and exothermic temperature.
Clinical Testing: None provided
Mimix is a trademark of Walter Lorenz Surgical, a Biomet Company Tyvek is a trademark of trademark of E.I. duPont de Nemours and Company α-BSM is a trademark of DePuy Pro Osteon is a trademark of Interpore Cross International
Norian and SRS are trademarks of Synthes
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which represent the department's mission to enhance the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation P.O Box 587 Warsaw, Indiana 46581-0587
Re: K041089
OSS Bone Graft System and OSS RapidSet Bone Graft System Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: July 19, 2004 Received: July 20, 2004
Dear Ms. Sandborn Beres:
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 (OS) regulation (21 CFR Part 820); and if
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Page 2 - Ms. Patricia Sandborn Beres
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you be object finding of substantial equivalence of your device to a premarket notification. - The PD Frinalis 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), If you desire specific at no for compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn other generalational 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,
l Mark H. Milken
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
4
510(k) Number (if known):
Device Name: OSS Bone Graft System and OSS RapidSet Bone Graft System
Indications For Use:
The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated
System of the Caster Charline (increating and nelvis) The USS Bone Grant System and the OOO Representities, spine and pelvis).
for filling bony voids of the skeletal system (i.e., the extremes defects creat for filling bony volus of the skeller system (r.c.) the exarch or osseous defects created
These defects may be surgically created osseous in intended for hope voids or i hese defects may be suigically created observes in intended for bone voids or
from disease or traumatic injury to the bone. The device is intentire from disease of traumatio injury to the structural integrity of the bony structure.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N Milker
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ K041089