(88 days)
The Conduit™ TCP Granules are indicated for filling bone voids or defects of the skeletal system (such as the extremities, 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. Conduit™ TCP Granules is a bone graft substitute that resorbs and is replaced with bone during the healing process.
Conduit™ TCP Granules are a synthetic material, obtained after high-temperature ceramicization of a mixture of tribasic calcium phosphate. The Conduit™ TCP Granules are composed of interconnected pores occupying approximately 70% of the volume of the implant, and ranging in diameter between 1 and 600 um. Conduit™ TCP Granules come in the form of irregular shaped granules having an average diameter between 1.5 and 3 mm inclusive.
The provided text describes a 510(k) premarket notification for "Conduit™ TCP Granules," a bone graft substitute. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed independent study with specific acceptance criteria and performance data.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, explicit numerical acceptance criteria are not stated, nor is a direct table showing performance against such criteria. The submission relies on "Physico-Chemical Characterization testing and animal testing" to demonstrate equivalence.
| Acceptance Criteria (Not Explicitly Stated, Inferred from Submission Type) | Reported Device Performance (Summary from Text) |
|---|---|
| Biocompatibility and Safety (Implied for bone graft substitutes) | Performance demonstrated through "Physico-Chemical Characterization testing and animal testing." The FDA's substantial equivalence determination implies these tests were sufficient to address safety and effectiveness concerns relative to predicates. |
| Material Composition | > 99% Beta-Tri Calcium Phosphate (β-ΤCP) Саз(РО4)2 |
| Porosity and Structure | Approximately 70% of the volume of the implant, with interconnected pores ranging in diameter between 1 and 600 um. |
| Granule Size | Irregular shaped granules having an average diameter between 1.5 and 3 mm inclusive. |
| Resorption and Bone Replacement | Stated as "a bone graft substitute that resorbs and is replaced with bone during the healing process" (Intended Use). |
| Substantial Equivalence to Predicate Devices | Determined by FDA as substantially equivalent to Orthovita VITOSS (K994337) and Pro Osteon 500R Resorbable Bone Graft Substitute (K990131). |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "Physico-Chemical Characterization testing and animal testing" were conducted. However, specific sample sizes for these tests are not provided.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective for the animal testing. Physico-chemical characterization is typically lab-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this 510(k) submission. For bone graft substitutes like Conduit™ TCP Granules, "ground truth" is typically established through:
- Standardized material characterization tests (e.g., chemical composition, porosity measurements).
- In vivo animal studies where outcomes are assessed histologically, radiographically, and sometimes mechanically by veterinary pathologists or specialized researchers.
- Clinical outcomes from predicate devices.
Expert consensus, in the sense of multiple human readers interpreting results, is not typically the primary method for establishing "ground truth" for the fundamental safety and efficacy of such a material for a 510(k) clearance based on substantial equivalence.
4. Adjudication Method for the Test Set
This is not applicable as there are no human readers or interpretations described that would require an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done or described in this submission. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This device is a bone graft substitute, not an imaging AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the "Conduit™ TCP Granules" device. This is a material device (bone graft substitute), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for showing the device meets its intended use and is safe/effective is established through:
- Physico-Chemical Characterization: Measurements of material properties like composition, porosity, and granule size, which are objectively verifiable.
- Animal Testing: In vivo studies to assess biocompatibility, resorption, and bone ingrowth. The "ground truth" in these studies would typically involve histopathology (examining tissue samples under a microscope) and potentially radiographic imaging (X-rays, CT scans) interpreted by trained veterinary pathologists and researchers.
8. The Sample Size for the Training Set
This question is not applicable. This device is a physical product (bone graft substitute), not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for this device.
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K014053 Conduit™ TCP Granules
510(k) Summary IX.
SUBMIT
8 2002 MAR
| TER: | DePuy AcroMed TM , Inc. |
|---|---|
| 325 Paramount Drive | |
| Raynham, MA 02767-0350 USA |
Karen F. Jurczak CONTACT PERSON:
December 07, 2001 DATE PREPARED:
Conduit™ TCP Granules PROPRIETARY NAME:
Bone Graft Substitute Material, Bone Void Filler CLASSIFICATION NAME:
PREDICATE DEVICE:
♦ Orthovita VITOSS (K994337) � Pro Osteon 500R Resorbable Bone Graft Substitute (K990131)
INTENDED USE:
The Conduit™ TCP Granules are indicated for filling bone voids or defects of the skeletal system (such as the extremities, 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. Conduit™ TCP Granules is a bone graft substitute that resorbs and is replaced with bone during the healing process.
MATERIALS:
99% Beta-Tri Calcium Phosphate (β-ΤCP) Саз(РО4)2
PERFORMANCE DATA:
Physico-Chemical Characterization testing and animal testing were conducted.
Conduit™ TCP Granules are a synthetic material, obtained DEVICE DESCRIPTION: after high-temperature ceramicization of a mixture of tribasic calcium phosphate. The Conduit™ TCP Granules composed of interconnected pores occupying are approximately 70% of the volume of the implant, and ranging in diameter between 1 and 600 um.
Conduit™ TCP Granules come in the form of irregular shaped granules having an average diameter between 1.5 and 3 mm inclusive.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The overall design is simple yet recognizable, representing the department's role in public health and welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2002
Mr. Frank Maas Director, Regulatory Affairs DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K014053
Conduit™ TCP Granules Regulatory Class: unclassified Product Code: MQV Dated: December 7, 2001 Received: December 10, 2001
Dear Mr. Maas:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becases on and the device is substantially equivalent (for the relerenced above and nave determined ire) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate conmicree prior to thay 20, 10, 10, 10, 10, 10, 2011, 10, 2011, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Allendinents, on to devroes that have onct (Act) that do not require approval of a premarket the Federal Pood, Drug, and Ocomette , therefore, market the device, subject to the general approval application (1111). I The general controls provisions of the Act include Condois provisions of the Fish - 110 gisting 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 II your device is classified (500 above) into sontrols. Existing major regulations affecting (FMA), it may of subject to Such adata veral Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas received.
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 I least that FDA has made a determination that your device complies with other requirements modifinal I DA mas made a actes and regulations administered by other Federal agencies. or the Act of ally 1 oderal bullated is requirements, including, but not limited to: registration 1 od inust compry with and 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), idositing systems (QS) regulation (21 CFR Part 820); and if
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Page 2 - Mr. Frank Maas
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter while in Jourse 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your at (301) 594-1637. The Office of Compliance at (301) 594-4639. Also, please note the ac regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general Manifacturers 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,
Sincerely yours,
Mark N Melkus
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
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Indications for Use IV.
510(k) Number (if known):
Conduit™ TCP Granules Device Name:
Indications For Use:
The Conduit™ TCP Granules are indicated for filling bone voids or defects of the skeletal The Colludil "TOP Orandies are indisated for the pelvis) that are not intrinsic to the system (Such as the "Extremator, "Spino, "and "and the surgically created osseous defects Stablity of the bony structure. "Those acrossive in the bone. Conduit™ TCP Granules is of Usseous delects created from tradination injury to the a with bone during the healing process.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use:(Per 21 CFR 801.109) | OR Over-The-Counter Use: |
| ivision Sign-Off)Division of General, Restorativeand Neurological Devices510(k) Number . |
§ 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.