(185 days)
Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the 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.
Norian SRS Bone Void Filler is an injectable, moldable and biocompatible bone void filler. The reactants pack contains sterile powder (calcium phosphate) and solution (dilute sodium phosphate) components. The reactants pack is designed to be placed in a reusable mixer where the two components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18 - 23°C. Norian SRS Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes at body temperature (37°C). Norian SRS Bone Void Filler is slowly resorbed over a period of years. The 3cc, 5cc, and 10 cc reactants packs are provided sterile and are for single use only.
The provided text describes a 510(k) submission for the Norian SRS Bone Void Filler. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data (animal studies), rather than a clinical study evaluating the device's diagnostic performance or human-in-the-loop improvements. Therefore, many of the requested categories related to diagnostic device performance evaluations are not applicable or cannot be answered from this document.
Here's an analysis of the available information:
Acceptance Criteria and Study Details (Based on available information)
| Characteristic | Details from provided text |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is demonstratsubstantial equivalence to predicate devices (Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler and Pro Osteon® 500R Resorbable Bone Graft Substitute) in terms of safety and effectiveness. This is based on the ability of the material to support bone growth into a metaphyseal defect, resorb over time, and be replaced by bone. Reported Device Performance: Pre-clinical animal data demonstrated that Norian SRS Bone Void Filler supports bone growth into a metaphyseal defect. It was shown to resorb over a period of time, accompanied by bone ingrowth and bone remodeling. This performance was deemed "as safe and effective as the predicate devices." |
| 2. Sample size and data provenance (Test Set) | Not applicable for a diagnostic performance test set. The data provenance is "Pre-clinical animal data." The specific animal sample size is not mentioned. |
| 3. Number of experts and qualifications (Ground Truth - Test Set) | Not applicable for this type of non-clinical, animal-based study. The "ground truth" would be histopathological findings and imaging from the animal models, interpreted by veterinary pathologists or researchers. The number and qualifications of these experts are not detailed in this submission summary. |
| 4. Adjudication method (Test Set) | Not applicable for this type of non-clinical study. |
| 5. MRMC Comparative Effectiveness Study | No. This is not a diagnostic device, and thus, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance is not applicable. |
| 6. Standalone Performance Study | Yes, in a way. The "Non-clinical performance data" section describes the device's performance in animal models in a standalone manner, demonstrating its ability to support bone growth and resorb. This is not "standalone algorithm performance" in the context of an AI/diagnostic device, but rather the device's intrinsic biological performance. |
| 7. Type of Ground Truth | The ground truth for the non-clinical study appears to be based on histopathology and imaging findings from animal models, demonstrating bone ingrowth, remodeling, and material resorption. |
| 8. Sample size for the training set | Not applicable. This is not an AI/machine learning device. The "training set" concept does not apply. |
| 9. How ground truth for training set was established | Not applicable. This is not an AI/machine learning device. |
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510(k) Summary
DEC 2 0 2001
| Sponsor: | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Contact: | Angela J. Silvestri(610) 647-9700 |
| Device Name: | Norian® SRS® Bone Void Filler |
| Device Classification: | 87 MQV - Unclassified - Filler, Calcium Sulfate Preformed Pellets |
| Predicate Device: | Vitoss™ Scaffold Synthetic Cancellous Bone Void FillerPro Osteon® 500R Resorbable Bone Graft Substitute |
| Device Description: | Norian SRS Bone Void Filler is an injectable, moldable andbiocompatible bone void filler. The reactants pack contains sterilepowder (calcium phosphate) and solution (dilute sodium phosphate)components. The reactants pack is designed to be placed in a reusablemixer where the two components are mixed together to form a smooth,viscous paste that remains injectable for approximately 5 minutes at 18- 23°C. Norian SRS Bone Void Filler begins to harden after 2 minutesand sets in approximately 10 minutes at body temperature (37°C).Norian SRS Bone Void Filler is slowly resorbed over a period ofyears. The 3cc, 5cc, and 10 cc reactants packs are provided sterile andare for single use only. |
| Indications for use: | Norian SRS Bone Void Filler is intended only for bony voids ordefects that are not intrinsic to the stability of the bony structure.Norian SRS Bone Void Filler is intended to be placed or injected intobony voids or gaps of the skeletal system (i.e., the extremities, spineand pelvis). These defects may be surgically created osseous defectsor osseous defects created from traumatic injury to the bone. Theproduct provides a bone void filler that resorbs and is replaced withbone during the healing process. |
| Non-clinicalperformance data: | Pre-clinical animal data demonstrate that Norian SRS Bone Void Fillersupports bone growth into a metaphyseal defect. These data show thatthe materials compared resorb over a period of time, accompanied bybone ingrowth and bone remodeling. These results, in conjunctionwith biocompatibility data, demonstrate that Norian SRS Bone VoidFiller is as safe and effective as the predicate devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes, (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K011897
Trade/Device Name: Norian® SRS® Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: October 9, 2001 Received: October 10, 2001
Dear Ms. Silvestri:
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 - Ms. Angela J. Silvestri
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogin maneting your mance of your device of your device to a legally premarket notheation: "The PDF intellig sification 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 and If you desire specific acrise for you in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compilance at (301) 594-1057. The at Compliance at (301) 594-4639. Also, please note the your device, preads connervanding by reference to premarket notification" (21CFR Part 807.97). Tegulation clittied, "Misormation on your responsibilities under the Act may be obtained from the Outler general information on your respontional 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,
Barbara Nyimumac for
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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Indications for Use Statement 2.0
Page of l of of ______________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | K011897 |
|---|---|
| --------------------------- | --------- |
Norian® SRS® Bone Void Filler Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Rastena hummmer
Division Sign-Off
Division of General, Restorative and Neurological Devices
510(k) Number K011897
CONFIDENTIAL
§ 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.