(31 days)
TriPore TDDHA, TDDBPS, and TDDgP15 is intended to be packed into bone defects of the skeletal system (extremities, posterolateral spine or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.
TriPore TDD is an open bore syringe prefilled with TriPore synthetic bone graft granules in three different compositions: (1) 100% pure hydroxylapatite; (2) biphasic mixture of 90% hydroxlyapatite and 10% tri-calcium phosphate; (3) biphasic mixture of 15% hydroxlyapatite and 85% tri-calcium phosphate TriPore TDD comes in two sizes - containing 5cc and 10cc of TriPore granules.
The provided documents describe a 510(k) premarket notification for the TriPore TDD device, which is a synthetic, porous calcium phosphate bone graft. This submission is for demonstrating substantial equivalence to predicate devices, not for a de novo marketing authorization or a PMA. Therefore, the information typically found in a study demonstrating specific performance against acceptance criteria for a novel device, especially in the context of AI/ML or diagnostic performance, is not present.
The submission focuses on proving that the TriPore TDD is essentially the same as already approved devices, rather than testing new performance metrics.
Based on the provided text, here's what can be extracted and what cannot be answered:
1. A table of acceptance criteria and the reported device performance
This information is not applicable/not provided in this type of 510(k) submission. The acceptance criteria here are related to demonstrating substantial equivalence in terms of material composition and delivery mechanism to predicate devices, not specific performance metrics against a defined threshold.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/not provided. There was no "test set" in the context of a new performance study. The data provenance refers to prior animal studies on the predicate device (TriPore, K070132), which were deemed applicable to the current device. The document explicitly states: "Extensive animal studies on TriPore, and recorded in K070132 apply to TriPore TDD and have not been repeated."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. There was no study with a "test set" requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. This device is a bone graft, not a diagnostic AI system or an imaging modality, so MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. As explained above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the prior animal studies referenced (K070132), the "ground truth" would likely be histological analysis and other biological assessments of bone ingrowth and material resorption, which are standard for evaluating bone grafts in animal models. However, the specifics for K070132 are not detailed in this document. For K110787, the "ground truth" for substantial equivalence relies on material identity.
8. The sample size for the training set
This information is not applicable/not provided. There was no training set in the context of the type of study typically associated with this question.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
Summary of the study and acceptance criteria from the provided document:
Acceptance Criteria for Substantial Equivalence (as implied by the submission):
The primary acceptance criterion for this 510(k) submission is that the TriPore TDD device is "substantially equivalent" to its predicate devices in terms of:
- Material Composition: The synthetic bone graft granules (TriPore HA, BP90, BP15) are identical to those in the predicate device TriPore K070132.
- Delivery Mechanism: The open bore syringe used is identical to the one in the predicate device FibriJet Graft Delivery Device K100754.
- Intended Use: The intended use is consistent with the predicate devices (packing into bone defects of the skeletal system for resorption and replacement with bone).
- Safety and Effectiveness: Demonstration that the device is safe, effective, and functions as well as the predicate devices based on the substantial equivalence argument.
Reported Device Performance / Determination of Substantial Equivalence:
The Orthogem Ltd concludes that the TriPore TDD is substantially equivalent based on the following:
- Non-Clinical Data: "Orthogem has determined that TriPore TDD is substantially equivalent to the predicate devices on the basis that the synthetic bone graft granules in TDD are exactly those in the predicate device."
- Animal Data: "Extensive animal studies on TriPore, and recorded in K070132 apply to TriPore TDD and have not been repeated. Animal data is not applicable to the TDD syringe." This means previous animal study data for the identical bone graft material (from K070132) was leveraged.
- Technological Characteristics Comparison: The submission explicitly states the TriPore TDD contains the exact same TriPore granules as K070132 and the exact same open bore syringe as K100754.
Conclusion by Orthogem:
"Orthogem concludes that the non-clinical tests carried out on TriPore TDD demonstrate that it is safe. Effective and function as well as the predicate devices."
The FDA's letter (K110787) confirms their agreement with this conclusion, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".
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APR 2 1 2011
Image /page/0/Picture/2 description: The image shows the word "Orthogem" in a simple, sans-serif font. To the left of the word is a graphic element that appears to be a stylized, three-dimensional shape composed of small dots or circles. The overall impression is clean and modern, suggesting a professional or corporate identity.
| Submitter | Orthogem LtdBiocityPennyfoot StreetNottingham NG1 1GF UK |
|---|---|
| Telephone | 011 44 115 9505721 |
| Facsimilie | 011 44 115 9505921 |
| Contact Person | Dr Wei-Jen Lo |
| Date prepared | 14 March 2011 |
| Trade Name | TriPore® TDD |
| Common Name | Synthetic, porous calcium phosphate bone graft |
| Classification | Resorbable calcium salt bone void filler devices have been classified bythe Orthopedics Device Panel as Class II Special Control per 21 CFR888.3045. Product code: MQV |
| Predicate Devices | (1)TriPore Calcium Phosphate granules K070132(2) FibriJet® Graft Delivery Device K100754 |
| Device Description | TriPore TDD is an open bore syringe prefilled with TriPore synthetic bonegraft granules in three different compositions: (1) 100% purehydroxylapatite; (2) biphasic mixture of 90% hydroxlyapatite and 10% tri-calcium phosphate; (3) biphasic mixture of 15% hydroxlyapatite and 85%tri-calcium phosphateTriPore TDD comes in two sizes - containing 5cc and 10cc of TriPoregranules. |
| Intended Use | TriPore TDDHA, TDDBP90, and TDDBP15 is intendedto be packed into bone defects of the skeletal system(extremities, posterolateral spine or pelvis) which are not intrinsic tothe stability of the bony structure. These defects may besurgically created voids or from traumatic injury to thebone. The device gradually resorbs and is replaced with boneduring the healing process. Rigid fixation techniquesshould be used in conjunction with this device. |
| TechnologicalCharacteristicscompared to thepredicate devices | (1) Predicate device TriPore K070132: TriPore TDD contains exactly thesame TriPore (HA or BP90 or BP15) as the predicate device.(2) Predicate device FibriJet Graft Delivery Device K100754: TriPore TDDcontains exactly the same open bore syringe as the predicate device. |
| Determination ofsubstantial equivalence(non-clinical data) | Orthogem has determined that TriPore TDD is substantially equivalent tothe predicate devices on the basis that the synthetic bone graft granulesin TDD are exactly those in the predicate device. |
| Determination ofsubstantial equivalence(animal data) | Extensive animal studies on TriPore, and recorded in K070132 apply toTriPore TDD and have not been repeated. Animal data is not applicable tothe TDD syringe. |
| Conclusions | Orthogem concludes that the non-clinical tests carried out on TriPore TDDdemonstrate that it is safe. Effective and function as well as the predicatedevices. |
| Other information deemed | None |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three wavy lines forming a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 2 1 2011
Orthogem Ltd % Dr. Wei Jen Lo Biocity, Pennyfoot Street Nottingham NG1 1GF United Kingdom
Re: K110787 Trade/Device Name: TriPore TDD Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 14, 2011 Received: March 25, 2011
Dear Dr. Lo:
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. Ilsting 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
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Page 2 - Dr. Wei Jen Lo
CFR Part 807); labeling (21 CFR Part 801); medical device 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Hy B. Rh
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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510(k) Number (if known):
Device Name: TriPore TDD
Indications For Use:
TriPore TDDHA, TDDBPS, and TDDgP15 is intended to be packed into bone defects of the skeletal system (extremities, posterolateral spine or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques
should be used in conjunction with this device.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use: NO (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 Sign-Qh)
Division of Surgical, Orthopedic, Divisionative Devices
510(k) Number K110787
Page 1 of 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.