(31 days)
No
The summary describes a synthetic bone graft material and its delivery system, with no mention of AI or ML capabilities.
Yes.
The device is intended to be packed into bone defects for healing, indicating a therapeutic purpose.
No
The device is a synthetic bone graft material intended for filling bone defects, not for diagnosis. It is absorbed and replaced by bone during healing.
No
The device description clearly states it is a prefilled syringe containing bone graft granules, which are physical materials intended for implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Intended Use: The intended use of TriPore TDDHA, TDDBPS, and TDDgP15 is to be packed into bone defects within the skeletal system. It is a bone graft material that is implanted directly into the body to aid in bone healing.
- Lack of Specimen Examination: The device does not examine any specimens from the human body in vitro. It is a therapeutic device used in vivo.
The information provided clearly describes a surgical implant used for bone repair, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (extremities, posterolateral spine or pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 Ltd
Biocity
Pennyfoot Street
Nottingham 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 by
the Orthopedics Device Panel as Class II Special Control per 21 CFR
888.3045. 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 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. |
| Intended Use | TriPore TDDHA, TDDBP90, and TDDBP15 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. |
| Technological
Characteristics
compared to the
predicate devices | (1) Predicate device TriPore K070132: TriPore TDD contains exactly the
same TriPore (HA or BP90 or BP15) as the predicate device.
(2) Predicate device FibriJet Graft Delivery Device K100754: TriPore TDD
contains exactly the same open bore syringe as the predicate device. |
| Determination of
substantial equivalence
(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. |
| Determination of
substantial equivalence
(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. |
| Conclusions | 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. |
| 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
3
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
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