(83 days)
Not Found
No
The summary describes a physical bone void filler made of calcium sulfate. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for filling bone voids or gaps and is replaced with bone during the healing process, clearly indicating its role in promoting healing and restoring physiological function.
No
The device is described as a bone void filler system, intended for physical filling of bony voids or gaps, and is not used to diagnose a medical condition.
No
The device description clearly states it is a physical implant made of calcium sulfate dihydrate, provided as pellets or a kit for paste, intended for filling bone voids. This is a hardware device, not software.
Based on the provided information, the Osteo-G Bone Void Filler System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the extremities, spine, or pelvis. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is a calcium sulfate dihydrate implant used as a bone graft substitute or bone void filler. This is a material implanted into the body, not a reagent or instrument used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on specimens taken from the human body. The Osteo-G Bone Void Filler System is a medical device used for surgical implantation to aid in bone healing.
N/A
Intended Use / Indications for Use
The Osteo-G Bone Void Filler System, pellets or paste, are intended for filling of bony voids or gaps, i. e., of the extremities, spine or pelvis, that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets or paste provide a bone void filler that is bioabsorbable and is replaced with bone during the healing process. Osteo-G Bone Void Filler System pellets or paste may be used at an infected site.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
The Osteo-G Bone Void Filler System is an osteoconductive, bioabsorbable, calcium sulfate dihydrate implant for use as a bone graft substitute or bone void filler. The system consists of prefabricated calcium sulfate dihydrate pellets or a kit for fabricating calcium suffate dihydrate implants to custom shape and size or for in situ use. The device is radiopaque and is presterilized for single use.
The Osteo-G Bone Void Filler System pellets are provided in three sizes, each with cylindrical shape, as follows:
- a) 5 mm diameter, 5 mm high
- b) 5 mm diameter, 3 mm high
- c) 3 mm diameter, 3 mm high
The Osteo-G Bone Void Filler System kit is provided in one size: a ten gram quantity of calcium sulfate hemihydrate powder component with a three milliliter mixing solution component. Once mixed, the powder and solution produce a moldable paste that can be custom shaped.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, spine or 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)
Not Found
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.
K010557, K963562, K963587, K010532, K991854, K003954, K013790
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
§ 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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ASpine USA Osteo-G Bone Void Filler System
KO313
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | ASpine USA
3645 Grand Avenue, Suite 104
Oakland, CA 94610 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Gordon Tao
President/CEO
Telephone (510) 251-6798
FAX (510) 251-6262 |
| Representative/Consultant: | Floyd G. Larson
PaxMed International
4329 Graydon Road
San Diego, CA 92130
Telephone (858) 792-1235
FAX (858) 792-1236 |
| DEVICE NAME | |
| Classification Name: | Filler, calcium sulfate preformed pellets |
| Trade/Proprietary Name: | Osteo-G Bone Void Filler System |
| Common Name: | bone void filler |
DEVICE CLASSIFICATION
Calcium sulfate preformed pellets have not been classified by FDA. On January 13, 1998, the Orthopaedic and Rehabilitation Devices Panel recommended that the calcium sulfate bone void filler device be assigned to Class II, Special Controls, and a Proposed Rule classifying the Resorbable Calcium Salt Bone Void Filler Device to Class II was issued by FDA in the Federal Register of February 7, 2002 (67 FR 5753). The Product Code for the device is MQV.
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CONFORMANCE WITH PERFORMANCE STANDARDS
No performance standards have been established under Section 514. Voluntary standards with which the Osteo-G Bone Void Filler System complies include American Society for Testing and Materials (ASTM) Standard F2224-03 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants, U.S.P. 24 N.F.-19, and ANSVAAMI/ISO 11137 Sterilization of Health Care Products - Radiation Sterilization.
INTENDED USE
The Osteo-G Bone Void Filler System, pellets or paste, are intended for filling of bony voids or gaps, i. e., of the extremities, spine or pelvis, that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets or paste provide a bone void filler that is bioabsorbable and is replaced with bone during the healing process. Osteo-G Bone Void Filler System pellets or paste may be used at an infected site.
DEVICE DESCRIPTION
The Osteo-G Bone Void Filler System is an osteoconductive, bioabsorbable, calcium sulfate dihydrate implant for use as a bone graft substitute or bone void filler. The system consists of prefabricated calcium sulfate dihydrate pellets or a kit for fabricating calcium suffate dihydrate implants to custom shape and size or for in situ use. The device is radiopaque and is presterilized for single use.
The Osteo-G Bone Void Filler System pellets are provided in three sizes, each with cylindrical shape, as follows:
- a) 5 mm diameter, 5 mm high
- b) 5 mm diameter, 3 mm high
- c) 3 mm diameter, 3 mm high
The Osteo-G Bone Void Filler System kit is provided in one size: a ten gram quantity of calcium sulfate hemihydrate powder component with a three milliliter mixing solution component. Once mixed, the powder and solution produce a moldable paste that can be custom shaped.
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Material Composition
The Osteo-G Bone Void Filler System pellets are made of calcium sulfate dihydrate with stearic acid as a processing aid. The Osteo-G Bone Void Filler System kit consists of powdered calcium sulfate hemihydrate and a mixing solution of purified water, glycerin, methylcellulose, and hydroxyethylcellulose. All calcium sulfate components have a purity of not less then 98% calcium sulfate, exclusive of water, when measured by USP 24 NF-19 or methods derived therefrom, as specified by ASTM Standard F2224-03.
EQUIVALENCE TO MARKETED PRODUCT
Aspine USA submits the following information and exhibits to demonstrate that, for the purposes of FDA's regulation of medical devices, the Osteo-G Bone Void Filler System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices.
The design and functional characteristics of the Osteo-G Bone Void Filler System and the predicate devices are substantially the same. They function by filling voids or gaps in non-loadbearing osseous defects. The predicate devices include the Smith & Nephew JAX Granules Bone Void Filler (K010557) Wright Plaster of Paris Pellets (K963562), the Wright Plaster of Paris Bone Void Filler Kit (K963587), the Osteoset BVF Kit (K010532), the Interpore Cross Osteoplast Bone Void Filler (K991854), the Biocomposites Ltd. Stimulan Calcium Sulfate Bone Void Filler Kit (K003954), and the Biomet Orthopedics Calcigen-S Bone Void Filler (K013790). All of these devices are intended to fill osseous voids or gaps and consist of calcium sulfate.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings of the serpent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 17 2003
ASpine USA, Inc. c/o Mr. Floyd G. Larson President PaxMed International 4329 Graydon Road San Diego, California 92130
Re: K031319
Trade Name: Osteo-G Bone Void Filler System Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: April 24, 2003 Received: April 25, 2003
Dear Mr. Larson:
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 - Mr. Floyd G. Larson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Office of 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 Division of Small Manufacturers, 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 vours.
Mark H. Millerson
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
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Device Name: Osteo-G Bone Void Filler System
Kozizlg
Indications for Use:
The Osteo-G Bone Void Filler System, pellets or paste, are intended for filling of bony voids or gaps, i. e., of the extremities, spine or pelvis, that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets or paste provide a bone void filler that is bioabsorbable and is replaced with bone during the healing process. Osteo-G Bone Void Filler System pellets or paste may be used at an infected site.
Mark N. Melkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031319
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
OR iv
Over-The-Counter Use