(90 days)
The BoneSource® BVF is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. The BoneSource® BVF is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e. extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
BoneSource® BVF is an injectable, self-setting, calcium phosphate cement that is biocompatible and bioresorbable.
This is a 510(k) summary for a medical device called BoneSource® BVF, a bone void filler. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial for a novel AI/software device would.
Therefore, the requested information elements related to AI/software device performance studies, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance, are not applicable to this type of submission.
Here's an analysis of what is provided and a best effort to address the prompt given the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The concept of "acceptance criteria" and "reported device performance" in this 510(k) summary is centered around demonstrating substantial equivalence to existing predicate devices, rather than meeting specific quantifiable performance metrics. The implicit acceptance criteria are that the device shares the same fundamental characteristics and intended use as the predicate devices, and that any differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance / Characteristics |
|---|---|
| Intended Use: Similar indications for use in treating bony voids/defects. | Intended for bony voids or defects not intrinsic to stability, placed into voids/gaps of the skeletal system (extremities, spine, pelvis). Resorbs and is replaced with bone. |
| Technological Characteristics: Similar materials, design, and operating principles. | Injectable, self-setting, calcium phosphate cement. Biocompatible and bioresorbable. |
| Materials: Composition comparable to predicate devices. | Calcium phosphate cement. (Specific composition not detailed, but implied to be similar to predicate HAC and SRS). |
| Safety: No new questions of safety. | Biocompatible. (Safety is implicitly established by substantial equivalence to legally marketed devices). |
| Effectiveness: No new questions of effectiveness. | Bioresorbable and replaced with bone during the healing process. (Effectiveness is implicitly established by substantial equivalence). |
2. Sample size used for the test set and the data provenance: Not applicable. This is a 510(k) premarket notification demonstrating substantial equivalence, not a clinical study with a "test set" in the context of AI/software performance. The "test" here is a comparison to predicate devices based on design, materials, and intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert consensus are concepts within clinical studies, typically for diagnostic or predictive devices. This submission reviews device characteristics and intended use in comparison to predicates.
4. Adjudication method for the test set: Not applicable for the reasons stated above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/software device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is not an AI/software device.
7. The type of ground truth used: Not applicable. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the predicate devices based on their prior market clearance and history of safe use.
8. The sample size for the training set: Not applicable. There is no "training set" in this context.
9. How the ground truth for the training set was established: Not applicable. There is no "training set" in this context.
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AUG - 4 2003
510(k) SUMMARY—BoneSource® BVF
| Submitter Name: | Howmedica Osteonics Corp. |
|---|---|
| Submitter Address: | 59 Route 17 Allendale, New Jersey 07401 |
| Contact Person: | Jennifer A. Daudelin, Regulatory Affairs Specialist |
| Phone Number: | 201-831-5379 |
| Fax Number: | 201-831-6038 |
| Date Prepared: | April 23, 2003 |
| Device Trade Name: | BoneSource® BVF |
| Device Common Name: | Hydroxyapatite Bone Void Filler |
| Classification Name and Number: | Filler, Calcium Sulfate Preformed Pellets 87 MQV |
| Predicate Device: | The BoneSource® BVF is substantially equivalent to the Stryker Instruments (Leibinger) BoneSource® HAC (K021440) and Synthes (USA) Norian® SRS® Bone Void Filler (K011897). |
| Device Description: | BoneSource® BVF is an injectable, self-setting, calcium phosphate cement that is biocompatible and bioresorbable. |
| Intended Use: | The BoneSource® BVF is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. The BoneSource® BVF is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e. extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. |
| Conclusion: | This device, with respect to materials, device characteristics and intended use, is substantially equivalent to the predicate devices. |
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Image /page/1/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right. The eagle's body is formed by three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2003
Ms. Debra Bing Manager, Regulatory Affairs Howmedica Osteonics Corporation 59 Route17 Allendale, New Jersey 07401-1677
Re: K031435
Trade/Device Name: BoneSource® BVF Regulatory Class: Unclassified Product Code: MQV Dated: May 5, 2003 Received: May 6, 2003
Dear Ms. Bing:
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. Iisting 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 - Ms. Debra Bing
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 yours,
Ella watts
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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510(k) Number (if known): K031435
Device Name:
BoneSource® BVF
Indications for Use:
The BoneSource® BVF is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. The BoneSource® BVF is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e. extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
signature
eral. Restorative and Neurological De
510(k) Number K031435
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription X Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.