(234 days)
No
The summary describes a synthetic bone graft material and its applicator, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a synthetic bone graft intended to be packed into bone defects, which directly contributes to the healing process and restoration of bone structure.
No
The device is a synthetic bone graft intended to fill bone defects, not to diagnose a condition.
No
The device description clearly states it is a "Synthetic bone graft granules" packed in an applicator, which are physical materials and a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a synthetic bone graft intended to be packed into bone defects of the skeletal system. This is a therapeutic and structural application within the body.
- Device Description: The device is described as synthetic bone graft granules. This is a material intended for implantation or placement within the body to aid in bone healing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) for a structural and therapeutic purpose.
N/A
Intended Use / Indications for Use
TriPore HA, TriPore BP90, TriPore BP15, is a synthetic bone graft intended to be packed into bone defects of the sketal 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
MQV
Device Description
Synthetic bone graft granules of one of the following three materials packed in a multi-purpose applicator (MPA):
(A) 100% pure hydroxylapatite (TriPore HA)
(B) biphasic mixture of 90% hydroxyapatite and 10% tri-calcium phosphate (TriPore BP90)
(C) biphasic mixture of 15% hydroxyapatite and 85% tri-calcium phosphate (TriPore BP15)
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
No clinical data were submitted. The synthetic bone graft granules are unchanged in composition and manufacture from the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2015
Orthogem Ltd. % Mr. Rod Ruston Priory Analysts Ltd. 15 Rudchesters Milton Keynes BG MK13 0PH United Kingdom
Re: K150064
Trade/Device Name: Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 15, 2015 Received: July 20, 2015
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. 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
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(21 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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150064
Device Name
Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
Indications for Use (Describe)
TriPore HA, TriPore BP90, TriPore BP15, is a synthetic bone graft intended to be packed into bone defects of the sketal 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Orthogem. K150064.
510(k) Summary
| Submitter/Owner | Orthogem Limited
BioCity
Pennyfoot Street
Nottingham
NN1 1GF
United Kingdom |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | 011 44 115 950 5721 |
| Facsimilie | 011 44 115 950 5921 |
| Contact Person | Rod Ruston BSc FRAPS |
| Date Prepared | 23 September 2014 |
| Trade Name | TriPore in a delivery device |
| Common Name | Synthetic, porous, bone graft granules of:
A) hydroxyapatite
B) biphasic tri-calcium phosphate:hydroxyapatite.
Nominal composition 90:10
C) biphasic tri-calcium phosphate:hydroxyapatite.
Nominal composition15:85 |
| Classification | Resorbable calcium salt bone void filler devices have been classified by
the Orthopedics Device Panel as Class II Special Controls per 21 CFR
888.3045.
Product code: MQV |
| Predicate Devices | TriPore (K070132)
TriPore TDD (K110787) |
| Device Description | Synthetic bone graft granules of one of the following three materials
packed in a multi-purpose applicator (MPA):
(A) 100% pure hydroxylapatite (TriPore HA)
(B) biphasic mixture of 90% hydroxyapatite and 10% tri-calcium
phosphate (TriPore BP90)
(C) biphasic mixture of 15% hydroxyapatite and 85% tri-calcium
phosphate (TriPore BP15) |
| Indications for Use | TriPore HA, TriPore BP90 and TriPore BP15 is synthetic bone graft
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. 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
Characteristics and
Substantial
Equivalence | TriPore HA, TriPore BP90 and TriPore BP15 is precisely the same as
the predicate device, K070132. When TriPore granules are packed into
an applicator, it performs exactly the same function as applicator in
the predicate in K110787. The sole difference is the materials and
processing used to manufacture the applicator. |
| Determination of
substantial
equivalence (non-
clinical data) | Orthogem has determined that TriPore in this application is
substantially equivalent to the predicate device on the basis of design
verification of the applicator. |
| Determination of
substantial
equivalence (clinical
data) | No clinical data were submitted. The synthetic bone graft granules are
unchanged in composition and manufacture from the predicate device. |
| Conclusions | Orthogem concludes that the verifications carried out on TriPore in a
delivery device demonstrate that it is safe, effective, and performs as
well or better than the predicate device. |
| Other information
deemed necessary by
the FDA | None. |
| Summary verification
statement | The submitter has verified that this summary includes only
information that is also contained in the body of the 510(k). This
summary does not contain any:
- puffery or unsubstantiated labeling claims
- raw data (that is, contains only summary data)
- trade secret or confidential information
- patient identification information |
(Continued on next page)
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