(105 days)
CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the 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. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
CarriGen Porous 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. CarriGen Porous Carrier Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Here's an analysis of the provided text regarding the CarriGen Porous Bone Substitute Material, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "acceptance criteria" for CarriGen are implicitly tied to demonstrating substantial equivalence to its predicate devices (OssiPro, EquivaBone Osteoinductive Bone Graft Substitute, and Gamma-bsm Moldable Bone Substitute Material). The document does not explicitly state quantitative acceptance criteria in terms of performance metrics with specific thresholds. Instead, it refers to "regression testing" as the method to demonstrate that changes do not affect the risk profile.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Substantial Equivalence to Predicate) | "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." |
| Intended Use Consistency | The stated intended use for CarriGen (filling bony voids/gaps in extremities, spine, pelvis; osteoconductive material that resorbs and is replaced by natural bone) aligns with the general characteristics of a bone void filler and is assumed to be substantially equivalent to the predicate devices' intended uses. |
| Material Composition Consistency | CarriGen's composition (Synthetic calcium phosphate, sodium carboxymethyl cellulose, sodium bicarbonate, and sodium carbonate) is presented, and its properties are described as similar to natural bone minerals and osteoconductive. This information implicitly supports consistency with the predicate device. |
| Physical and Chemical Properties (e.g., Conversion to apatitic calcium phosphate, Low crystalline order, osteoconductivity, resorption) | Described as: "harden at body temperature and convert 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. CarriGen Porous Carrier Bone Substitute Material is an osteoconductive material that resorbed and replaced by natural bone over time." This description supports the expected performance characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "regression testing" but does not provide details on the number of samples or cases used for this testing.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence through "regression testing" against existing predicate devices and a guidance document, rather than clinical studies requiring expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
This information is not provided. As no details about expert ground truth or a clinical test set are included beyond "regression testing," no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not applicable and not provided. The device is a bone graft substitute material, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. The device is a physical bone graft substitute material, not a software algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in AI/diagnostic device evaluation (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. The "proof" is based on demonstrating that modifications to an already cleared device (OssiPro) do not alter its safety or effectiveness, as assessed through "regression testing" against a guidance document and comparison to predicates. The implicit "ground truth" is that the predicate devices are safe and effective for their intended use.
8. The Sample Size for the Training Set
This information is not provided. The document describes a medical device, not an AI algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As explained above, this is a physical medical device, not an AI algorithm with a training set and associated ground truth establishment.
Summary of the Study:
The "study" described in this 510(k) submission is referred to as "Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device."
- Purpose: To demonstrate that the proposed changes to the predicate devices (OssiPro, EquivaBone, Gamma-bsm) do not affect the risk profile of the devices, thereby maintaining substantial equivalence for the modified CarriGen Porous Bone Substitute Material.
- Methodology (as implied): The specific tests performed under "regression testing" are not detailed, but they would typically involve physico-chemical characterization, mechanical testing, biocompatibility evaluations, and potentially in-vitro or in-vivo studies to confirm that the modified material's properties (such as setting time, conversion to apatitic calcium phosphate, porosity, osteoconductivity, and resorption rate) remain within acceptable limits and are comparable to the predicate devices and the requirements of the Special Controls Guidance Document.
- Conclusion: The submission of this testing was deemed sufficient by the FDA to issue a substantial equivalence determination, implying that the CarriGen device met the unstated acceptance criteria embedded within the guidance document and the substantial equivalence pathway.
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10934477
Special 510(k) Submission - CarriGen (OssiPro) Modification
5. 510(k) Summary
FEB 1 8 2010
FEB 18 2010
| Submitter: | ETEX Corporation38 Sidney StreetCambridge, MA 02139Registration No.: 1225112Owner/Operator No.: 9014709 |
|---|---|
| Contact Person: | Christopher KlaczykRegulatory Affairs ManagerOffice: (617) 577-7270 x160Mobile: (617) 710-8091Fax: (617) 577-7170E-Mail: cklaczyk@etexcorp.com |
| Date Prepared: | November 4, 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: CarriGen® Porous Bone Substitute Material
Predicate Device(s): OssiPro (ETEX Corp., K062630)
EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corp., K090855)
Gamma-bsm Moldable Bone Substitute Material (ETEX Corp., K091607)
Device Description: CarriGen Porous 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
hydroxyapatite (PCHA), is of low crystalline order with a
The end product, poorly crystalline
material.
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similar chemical and crystalline structure to that of natural bone minerals. CarriGen Porous Carrier Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Intended Use: CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the 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. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Materials: Synthetic calcium phosphate, sodium carboxymethyl cellulose, sodium bicarbonate, and sodium carbonate.
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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with flowing lines, positioned to the right of the text. The text, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," is arranged in a circular fashion around the left side of the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
ETEX Corp. c/o Christopher Klaczyk 38 Sidney Street Cambridge, Massachusetts 02139
FEB 1 8 2010
Re: K093447
Trade/Device Name: CarriGen Porous Bone Substitute Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: January 15, 2010 Received: January 19, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
the country of the country of the county of 、
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Page 2 - Mr. Klaczyk
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807:97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Laurence V. Berger
ACTING
DSORD DIRECTOR
For Mark N. Melkerson · Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Submission - CarriGen (OssiPro) Modification
4. Indications For Use
510(k) Number (if known):
Device Name:
CarriGen® Porous Bone Substitute Material (originally cleared as OssiPro)
Indications for Use:
CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the 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. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
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)
FOR M. MELKERSON
(Division Sign-Off) Division of Surgical Orthopedic. and Restorative Devices
510(k) Number K093447
ETEX Corporation
Page 4-1
§ 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.