Beta-bsm Injectable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta-bsm Injectable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Gamma-bsm Moldable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Description

Beta-bsm Injectable Bone Substitute Material is synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site by injection or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

AI/ML Overview

The provided document is a 510(k) premarket notification for two bone substitute materials, Beta-bsm Injectable Bone Substitute Material and Gamma-bsm Moldable Bone Substitute Material.

The document states under "Performance Data" for both devices:

"Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices."

This indicates that the submission relies on regression testing to demonstrate that the proposed changes to the predicate devices do not negatively impact their safety and effectiveness. This is a common approach for modifications to already cleared devices. It does not describe a de novo study evaluating the performance of the device against newly established acceptance criteria in the same way a novel device might be assessed. Instead, it suggests that the acceptance criteria are implicitly linked to maintaining the established risk profile of the predicate devices.

Therefore, the requested information about a new study with explicit acceptance criteria, sample sizes, expert involvement, and specific performance metrics for the current submission's devices is not detailed in this 510(k) summary. The document points to adherence to a guidance document for resorbable calcium salt bone void fillers as the basis for performance data.

Based on the provided text, a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone studies, and how ground truth for training data were established cannot be fully extracted or described because the submission relies on regression testing against predicate device performance.

General Interpretation of the Document Regarding Performance:

Acceptance Criteria: While not explicitly listed with numeric targets, the acceptance criteria are implied to be that the proposed changes to Beta-bsm and Gamma-bsm do not affect the risk profile of their respective predicate devices. This means the performance should be comparable to or not worse than the predicate devices' established performance. The "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device" would outline the general expectations and testing methodologies for this type of device.
Reported Device Performance: The document states that "Regression testing... has been submitted to show that the proposed changes... do not affect the risk profile." This is the reported performance – a demonstration of equivalence in risk profile, rather than a quantifiable performance metric for the current devices themselves.

In summary, this 510(k) is for a modification/predicate comparison, not a de novo study of a new device's absolute performance against novel acceptance criteria. Therefore, most of your specific questions are not directly answerable from this text.

Summary

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K090242

1. 510(k) Summary
5.1 510(k) Summary - Beta-bsm
Submitter:

FEB 2 0 2009

ETEX Corporation 38 Sidney Street Cambridge, MA 02139 Registration No .: 1225112 Owner/Operator No .: 9014709

Christopher Klaczyk Contact Person: Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 Fax: (617) 577-7170 cklaczyk@etexcorp.com E-Mail:

Date Prepared: January 30, 2009

Product Code(s): MQV (21 CFR 888.3045) _

II (21 CFR 888.3045) Device Class:

Classification Panel: Orthopaedics

FDA Panel Number: 87

Classification Name: Filler, Bone Void, Calcium Compound (21 CFR 888.3045)

Proprietary Name: Beta-bsm Injectable Bone Substitute Material

Predicate Device(s): Beta-bsm Injectable Bone Substitute Material (cleared as OssiFuse Bone Substitute Material, K072355) α-ΒSM (Κ072636)

Device Description: Beta-bsm Injectable Bone Substitute Material is synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a syringe-to-syringe mixing The resulting paste can be administered to the svstem. treatment site by injection or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product,

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poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

Intended Use:

Materials:

Performance Data:

Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices.

Synthetic calcium phosphate

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5.2 510(k) Summary - Gamma-bsm

Submitter:

ETEX Corporation 38 Sidney Street Cambridge, MA 02139 Registration No .: 1225112 Owner/Operator No .: 9014709

Contact Person:

Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 Fax: (617) 577-7170 cklaczyk@etexcorp.com E-Mail:
Date Prepared: January 30, 2009

Product Code(s): MQV (21 CFR 888.3045)

Device Class: II (21 CFR 888.3045)

Classification Panel: Orthopaedics

FDA Panel Number: 87

Classification Name: Filler, Bone Void, Calcium Compound (21 CFR 888.3045)

Proprietary Name: Gamma-bsm Moldable Bone Substitute Material

Predicate Device(s): Gamma-bsm Moldable Bone Substitute Material (cleared as CaP3 Bone Void Filler, K033138) α-ΒSM (Κ072636)

Device Description: Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorlv crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute

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Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

Gamma-bsm Moldable Bone Substitute Material is an Intended Use: implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Synthetic calcium phosphate

Materials:

Performance Data:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The eagle is facing to the right. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ETEX Corporation % Mr. Christopher Klaczyk Regulatory Affairs Manager 38 Sidney Street, 3 Floor The Clark Building Cambridge, Massachusetts

FEB 2009

Re: K090242

Trade/Device Name: Beta-bsm Injectable Bone Substitute Material Gamma-bsm Moldable Bone Substitute Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: January 30, 2009 Received: February 2, 2009

Dear Mr. Klaczyk:

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. Christopher Klaczyk

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications For Use

4.1 Indications For Use - Beta-bsm

510(k) Number (if known):

Device Name:

Beta-bsm Injectable Bone Substitute Material (originally cleared as OssiFuse Bone Substitute Material)

Indications for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number	K090242
---------------	---------

ETEX Corporation

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Indications For Use - Gamma-bsm 4.2

510(k) Number (if known):

Device Name:

Gamma-bsm Moldable Bone Substitute Material (originally cleared as CaP3 Moldable Bone Void Filler)

Indications for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkers

(Divisior, Sign-6 Division of General, Rectorative, and Neurological I avoces

510(k) Numbe: K090242

ETEX Corporation

Regulation Number and Section

§ 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.