(35 days)
α-BSM Bone Substitute Material is indicated for 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. «-BSM Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.
α-BSM Bone Substitute Material is a synthetic, biocompatible calcium phosphate implantable paste that hardens at body temperature and converts to an apatitic calcium phosphate. It is provided in single use packages containing either 2.5, 5.0 or 10 grams (nominal) of a-BSM powder in a mixing bulb, sterile mixing solution, an appropriately sized syringe, and a 16 gauge needle.
α-BSM Bone Substitute Material is supplied sterile for single patient use. The product is packaged in a clear plastic sterilization pouch (with a second outer sterility barrier) containing: a unit does of sterile a-BSM Bone Substitute Material (dry, white powder) contained with an elastomeric (silicone) mixing bulb (available in 2.5, 5.0 or 10cc dose sizes) with a septum closure, a sterile syringe, a 16 gauge needle, and a vial of sterile saline. The saline is injected aseptically into the mixing bulb and the material is mixed by kneading the bulb with the fingers. Once the liquid and powder are well mixed, the bulb is opened and the material, now in paste form, can be administered to the site via a syringe or by manual application. The material can be shaped into the desired form prior to application or shaped in situ in the defect. The setting process occurs in vivo at neutral pH and is non-exothermic and non-caustic.
α-BSM Bone Substitute Material is synthesized from reagent grade inorganic raw materials composed of salts of calcium and phosphates. There are no substances of biological origin used in the synthesis or processing of the product. No additional preservatives or medicinal substances are present.
This 510(k) submission for the α-BSM Bone Substitute Material is a Special 510(k), which indicates that the device undergoes minor modifications compared to a previously cleared predicate device. Special 510(k)s typically focus on demonstrating that the changes do not significantly alter the device's safety or effectiveness, and therefore, extensive new clinical studies with detailed acceptance criteria might not be required in the same way as for novel devices.
Based on the provided text, the submission relies on demonstrating substantial equivalence to the predicate device (α-BSM Bone Substitute Material cleared in K011048) rather than presenting new performance data against a specific set of acceptance criteria from a new study.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
There is no explicit table of acceptance criteria or new reported device performance data presented in the provided document. The submission's core argument is substantial equivalence to a predicate device based on commonalities:
| Feature/Criterion | Predicate Device (K011048) | Subject Device (K072636) | Assessment/Comment |
|---|---|---|---|
| Indicated Use | Same | Same | Substantially Equivalent |
| Operating Principle | Same | Same | Substantially Equivalent |
| Materials | Same | Same | Substantially Equivalent |
| Shelf Life | Same | Same | Substantially Equivalent |
| Sterilization Processes | Same | Same | Substantially Equivalent |
| Manufacturer | Same | Same | Substantially Equivalent |
| Modifications | N/A | Minor modifications in labeling, IFU, and part numbers | Not significantly different from predicate |
2. Sample Size Used for the Test Set and Data Provenance
No new test set data is presented in this Special 510(k) submission to demonstrate performance against new acceptance criteria. The claim is based on the previously established performance of the predicate device. Therefore, no information on sample size for a new test set or its provenance is available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no new test set data is presented for this specific submission, there is no mention of experts used to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no new test set data is presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a bone substitute material, not an imaging or diagnostic device that would typically involve human readers for interpretation. Its effectiveness is assessed through its physiological performance (resorption and replacement with bone), which would be evaluated in studies (likely pre-clinical or clinical studies for the original predicate device) by clinical and histological outcomes, not human reader interpretation of images.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical bone substitute material, not an algorithm.
7. Type of Ground Truth Used
For the original predicate device (K011048) upon which this submission's substantial equivalence is based, the "ground truth" would have been established through clinical and/or pre-clinical studies demonstrating:
- Biocompatibility: Absence of adverse reactions.
- Resorption rates: How quickly the material breaks down.
- Bone ingrowth/replacement: Evidence of new bone formation.
- Mechanical integrity: Ability to fulfill its function.
This would involve histology (pathology) to observe cellular activity and bone formation, and potentially imaging (X-ray, CT) to assess filling of voids and radiographic bone density changes, and clinical outcomes data related to patient recovery and functional improvement.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
In summary: This Special 510(k) relies on the prior clearance of a predicate device. The "acceptance criteria" are implicitly met by demonstrating that the modifications made to the device (labeling, IFU, part numbers) do not alter the fundamental characteristics or performance that allowed the predicate device to be cleared. No new studies or performance data are presented in this document for the K072636 submission itself.
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ETEX Corporation Medical Device Special 510(k) Submission α-BSM Bone Substitute Material K072636
510(k) SUMMARY AS REQUIRED UNDER 21 CFR 807.87(h)
| 1. | Submitted By: | ETEX Corporation38 Sidney Street, 3rd FloorCambridge, MA 02139 | OCT 23 2007 | ||
|---|---|---|---|---|---|
| Contact Person: | Pamela W. Adams, R.A.C.Senior Vice President and Chief OperatingOfficer | ||||
| Date Prepared: | September 12, 2007 | ||||
| FDA EstablishmentNumber: | 1225112 | ||||
| 2. | Proprietary Name:Common Name:Device Class:Product Code: | α-BSM Bone Substitute MaterialBone Void FillerClass IIMQV | |||
| 3. | Legally Marketed Device for Substantial Equivalence Comparison:Product: α-BSM Bone Substitute Material |
Product Code: MQV Device Class: Class II Manufacturer: ETEX Corporation K011048 510(k) #:
4. Comparison to the Predicate Device:
The subject a-BSM Bone Substitute Material is a synthetic bone substitute material that is substantially equivalent to «-BSM Bone Substitute Material cleared in K011048. Both a-BSM have the same indicated use; use the same operating principle; incorporate the same materials; have the same shelf life; are sterilized using the same processes; and have the same manufacturer.
Modifications in the subject a-BSM from the predicate device are minor modifications in labeling. IFU, and change in part numbers.
5. Device Description:
«-BSM Bone Substitute Material is a synthetic, biocompatible calcium phosphate implantable paste that hardens at body temperature and converts to an apatitic calcium phosphate. It is provided in single use packages containing either 2.5, 5.0 or 10 grams (nominal) of a-BSM
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ETEX Corporation Medical Device Special 510(k) Submission α-BSM Bone Substitute Material K072636
powder in a mixing bulb, sterile mixing solution, an appropriately sized syringe, and a 16 gauge needle.
«-BSM Bone Substitute Material is supplied sterile for single patient use. The product is packaged in a clear plastic sterilization pouch (with a second outer sterility barrier) containing: a unit does of sterile a-BSM Bone Substitute Material (dry, white powder) contained with an elastomeric (silicone) mixing bulb (available in 2.5, 5.0 or 10cc dose sizes) with a septum closure, a sterile syringe, a 16 gauge needle, and a vial of sterile saline. The saline is injected aseptically into the mixing bulb and the material is mixed by kneading the bulb with the fingers. Once the liquid and powder are well mixed, the bulb is opened and the material, now in paste form, can be administered to the site via a syringe or by manual application. The material can be shaped into the desired form prior to application or shaped in situ in the defect. The setting process occurs in vivo at neutral pH and is non-exothermic and non-caustic.
«-BSM Bone Substitute Material is synthesized from reagent grade inorganic raw materials composed of salts of calcium and phosphates. There are no substances of biological origin used in the synthesis or processing of the product. No additional preservatives or medicinal substances are present.
Indications for Use 6.
«-BSM Bone Substitute Material is indicated for 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. «-BSM Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.
7. Substantial Equivalence
In summary, the &-BSM Bone Substitute Material described in this submission is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem is a symbol of human services, resembling an abstract representation of people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2007
ETEX Corporation % Ms. Pamela W. Adams, R.A.C. Senior Vice President & Chief Operating Officer 38 Sidney Street Cambridge, MA 02139
Re: K072636
Trade/Device Name: α-BSM® 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: September 17, 2007 Received: September 24, 2007
Dear Ms. Adams:
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. Pamela W. Adams, R.A.C.
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 A. Mellers
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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ETEX Corporation Medical Device Special 510(k) Submission α-BSM Bone Substitute Material K072636
INDICATIONS FOR USE STATEMENT
210(K) Number K072636 (if known)
α-BSM® Bone Substitute Material Device Name
Indications for use
α-BSM Bone Substitute Material is indicated for 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. «-BSM Bone Substitute Material is a bone graft substitute 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)
(Division Sign-Off)
Division of General. Restorative,
and Neurological Devices
| 510(k) Number | K072636 |
|---|---|
| --------------- | --------- |
| Prescription Use ✓ | OR | Over-The Counter Use |
|---|---|---|
| --------------------------------------------------------------------- | ---- | ------------------------------------------------------------------------ |
(Per 21 CFR 801.109)ETEX Corporation Special 510(k) α-BSM® Bone Substitute Submission
§ 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.