(178 days)
TriPore HA, TriPore BP90 and TriPore BP15 is intended to be packed into bone defects of the skeletal system (extremities, 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. This device can also be used for maxillofacial surgery for the reconstruction of the facial skeleton. 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 HA is pure hydroxylapatite bone void filler, with a highly porous structure comprising three types of porosity which are interconnected: macropores (100 µm to 1-2mm), midipores (10-100 µm) and microspaces (1-10 µm).
TriPore BP90 and TriPore BP15 are a biphasic tricalcium phosphate:hydroxylapatite. The (X) designates the nominal hydroxyapatite composition of the mixture. TriPore BP bone void filler has the same structure as TriPore HA.
TriPore (HA or BP) is available in Blocks (D-shaped, cuboid and other shapes) and Granules (four different sizes)
The provided text describes a medical device called TriPore (HA, BP90, BP15), which is a resorbable calcium salt bone void filler. The document is a 510(k) summary, detailing its substantial equivalence to a predicate device for market clearance.
However, the text does not contain information about:
- Specific acceptance criteria expressed as performance metrics (e.g., sensitivity, specificity, accuracy).
- A "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or algorithm performance study with quantitative results.
- Sample sizes for test sets or training sets.
- Data provenance, number of experts, adjudication methods, or ground truth establishment for such studies.
- MRMC comparative effectiveness studies or standalone algorithm performance.
The document primarily focuses on non-clinical and animal data to establish substantial equivalence. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and performance metrics as they are not present in the provided text.
The closest relevant information, though not directly addressing your specific questions about modern AI/imaging device performance studies, is summarized below:
Acceptance Criteria and Device Performance (Based on "Determination of substantial equivalence" sections):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence (Non-Clinical Data) | Determined on the basis of chemical composition tests on both TriPore and the predicate device (Vitoss™) as prescribed in the 'Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device" (FDA Guidance Document 855, dated June 2, 2003). TriPore itself complies with the requirements of this Special Controls Document. |
| Substantial Equivalence (Animal Data) | Animal studies making direct comparison against the predicate device concluded that at 24 weeks implant, TriPore implants were structurally more integral with interconnecting walls and bone present within the macro pores, midi pores, and micro spaces compared to the predicate device. |
| Safety and Effectiveness Conclusion | Orthogem concludes that the non-clinical and animal tests demonstrate TriPore is safe, effective, and performs as well as or better than the predicate device. |
Missing Information:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The animal study mentions "animal studies" but gives no sample size or details about the cohort.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided, as this is not an imaging/AI study with expert-labeled ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
- 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: Not applicable. This is not an AI-assisted device in that context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical data, it was "chemical composition tests." For the animal data, it was histological or structural analysis of implants at 24 weeks, likely interpreted by animal scientists/pathologists, but the specifics are not detailed.
- The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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5 510(k) Summary as required by Section 807.92(c)
| Submitter | Orthogem LimitedBioCityPennyfoot StreetNottinghamNN1 1GFUnited Kingdom |
|---|---|
| Telephone | 011 44 115 854 9486 |
| Facsimilie | 011 44 115 854 2808 |
| Contact Person | Rod Ruston BSc RAC |
| Date Prepared | |
| Trade Name | TriPore HATriPore BP90TriPore BP15 |
| Common Name | 1)Synthetic, porous hydroxylapatite: TriPore HA2)Synthetic, porous biphasic tricalciumphosphate/hydroxylapatite: TriPore BP90: nominal90% HA with 10% tricalcium phosphate3)Synthetic, porous biphasic tricalciumphosphate/hydroxylapatite TriPore BP15: nominal15% HA with 85% tricalcium phosphate |
| Classification | Resorbable calcium salt bone void filler devices havebeen classified by the Orthopedics Device Panel asClass II Special Controls per 21 CFR 888.3045.Product code: MQV |
| Predicate Device | Orthovita Vitoss™ |
| Device Description | TriPore HA is pure hydroxylapatite bone void filler, witha highly porous structure comprising three types ofporosity which are interconnected: macropores (100µm to 1-2mm), midipores (10-100 µm) and microspaces(1-10 µm).TriPore BP90 and TriPore BP15 are a biphasictricalcium phosphate:hydroxylapatite. The (X)designates the nominal hydroxyapatite composition ofthe mixture. TriPore BP bone void filler has the samestructure as TriPore HA.TriPore (HA or BP) is available in Blocks (D-shaped,cuboid and other shapes) and Granules (four differentsizes) |
| Intended Use | TriPore HA, TriPore BP90 and TriPore BP15 is intended to be packed into bone defects of the skeletal system (extremities, 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. This device can also be used for maxillofacial surgery for the reconstruction of the facial skeleton. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device. |
| Technical Characteristicsand SubstantialEquivalence | Both the predicate device, Vitoss and TriPore (HA and BP) share similar characteristics in that they are both calcium salt bone void fillers covered by 'Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device" (FDA Guidance Document 855, dated June 2, 2003). Both have a porous structure which promotes bone ingrowth. They are available in blocks or granules (TriPore) and morsels (Vitoss). They differ from each other in two main aspects:1) the pore size and distribution2) the material - Vitoss is manufactured from pure tricalcium phosphate. TriPore HA is manufactured from pure hydroxylapatite. TriPore BP is manufactured from a mixture of pure tricalcium phosphate and pure hydroxylapatite. |
| Determination ofsubstantial equivalence(non-clinical data) | Orthogem has determined that TriPore is substantially equivalent to the predicate device on the basis of chemical composition tests on both devices as prescribed in the 'Class II Special Controls Guidance Document' referenced above.Secondly, TriPore itself complies with the requirements of the Special Controls Document referred to above. |
| Determination ofsubstantial equivalence(animal data) | Animal studies making direct comparison against the predicate device concluded that at 24 weeks implant, TriPore implants were structurally more integral with interconnecting walls and bone present within the macro pores, midi pores and micro spaces. |
| Conclusions | Orthogem concludes that the non-clinical and animal tests discussed above demonstrate that TriPore is safe, effective and performs as well as or better than the predicate device. |
| Other information deemednecessary by the FDA | None more than that required by 'Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device" (FDA Guidance Document 855, dated June 2, 2003) |
and production and comments of the research and the result of the
Onhogem, TnPore 510(K), K070132
510(k) Summary V3/Part 5/Page 5.1 CONFIDENTIAL
pg 1 of 2
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Image /page/1/Picture/0 description: The image contains two lines of handwritten numbers. The first line reads 'K070132', and the second line reads '500364' with a horizontal line drawn through the first two digits. The numbers are written in a casual, slightly messy style.
Orthogem. TriPore 510(k). K070132
510(k) Summary V4/Part 5/Page 5.2
CONFIDENTIAL
pg 2 of 2
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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 caduceus, which is a symbol of medicine and health, with three parallel lines forming the wings of the symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
JUL 1 8 2007
Food and Drug Administration 9200 Corporate Boulevard
Public Health Service
Rockville MD 20850
Orthogem Limited % Mr. Rod Ruston Project Manager Biocity Pennyfoot Street Nottingham NG1 IGF United Kingdom
Re: K070132
Trade/Device Name: TriPore HA, TriPore BP90, TriPore BP15 Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV Dated: June 18, 2007 Received: June 20, 2007
Dear Mr. Ruston:
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
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Page 2 - Mr. Rod Ruston
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 Mckenn
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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સ્ક્રમ્ડ્સ્ક્ટ
Indications for Use
510(k) Number (if known): K070132
Device Name: TriPore HA, TriPore BP90, TriPore BP15
Indications For Use:
TriPore HA, TriPore BP90 and TriPore BP15 is intended to be packed into bone defects of the skeletal system (extremities, 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. This device can also be used for maxillofacial surgery for the reconstruction of the facial skeleton. 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)
510(k) Ni
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)
Marta A. Millerson
estorative,
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.