(66 days)
K994337, K01405
Not Found
No
The summary describes a bone void filler made of calcium phosphate, a physical material. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML.
Yes
The device is a bone void filler intended to fill bony voids or gaps caused by trauma or surgery, which is a therapeutic purpose.
No
The device is a bone void filler intended to fill bony voids or gaps; it is not described as diagnosing any condition or disease.
No
The device is a bone void filler, which is a physical implant made of calcium phosphate. It is a hardware device, 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 CAMCERAM TCP is a "bone void filler" intended to fill bony voids or gaps in the body. This is a therapeutic or structural purpose, not a diagnostic one.
- Device Description: The description details the material composition (calcium phosphate) and form (granules, block) of a resorbable implant. This aligns with a medical device used within the body, not a diagnostic test performed on samples outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
CAMCERAM TCP is a resorbable bone void filler intended to fill bony void 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.
CAMCERAM TCP is a bone void filler is a resorbable implant intended to fill bony void 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.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
CAMCERAM TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a beta-Tricalcium Phosphate and is 90% porous. The product is provided sterile available in granules 1-4 mm and a block form.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, spine, and 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)
The CAMCERAM TCP and the predicate devices are all similar in design, materials of construction and function. CAMCERAM TCP has been compared in physico-chemical testing with the predicate devices which confirmed the composition and resorption profile. The safety and biocompatibility testing performed for calcium phosphates and the long history of safe clinical use for tricalcium phosphate products support the safe use of CAMCERAM TCP. CAMCERAM TCP meets the applicable requirements of the FDA guidance documents on bone void fillers.
The CAMCERAM TCP is tested to conform to the recognized standard, ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for suregical Implantation". The devices to which the CAMCERAM TCP claims substantial equivalence are the Vitoss scaffold (Orthovita) and Conduit TCP (Depuy Acromed) have been used safely for many years in the clinical environment.
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.
Vitoss scaffold (OrthoVita), K994337, Conduit TCPgranules (Depuy Acromed), K01405
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.
0
510(k) Summary for CAMCERAM TCP
SPONSOR 1.
Name : CAM implants BV Address: Zernikedreef 6, Leiden, The Netherlands Contact Person: Kim Groenewegen van der Weijden Telephone: +31 (0)71 5240624 Facsimile: +31 (0)71 5240690
Date Prepared: February 2005
2. DEVICE NAME
| Proprietary Name: | CAMCERAM TCP |
|---|---|
| Common/Usual Name: | Bone void filler |
| Classification Name: | Bone void filler |
3. PREDICATE DEVICES
| Proprietary Name: | Vitoss scaffold (OrthoVita), K994337 |
|---|---|
| Proprietary Name: | Conduit TCPgranules (Depuy Acromed), K01405 |
DEVICE DESCRIPTION 4.
CAMCERAM TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a beta-Tricalcium Phosphate and is 90% porous. The product is provided sterile available in granules 1-4 mm and a block form.
INTENDED USE ਨੰ
CAMCERAM TCP is a resorbable bone void filler intended to fill bony void 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.
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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The CAMCERAM TCP and the predicate devices are all similar in design, materials of construction and function. CAMCERAM TCP has been compared in physico-chemical testing with the predicate devices which confirmed the composition and resorption profile. The safety and biocompatibility testing performed for calcium phosphates and the long history of safe clinical use for tricalcium phosphate products support the safe use of CAMCERAM TCP. CAMCERAM TCP meets the applicable requirements of the FDA guidance documents on bone void fillers.
7. TESTING
The CAMCERAM TCP is tested to conform to the recognized standard, ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for suregical Implantation". The devices to which the CAMCERAM TCP claims substantial equivalence are the Vitoss scaffold (Orthovita) and Conduit TCP (Depuy Acromed) have been used safely for many years in the clinical environment.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health, services, and people. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Public Health Service
APR 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rutger Kuipers Manager QA/RA CAM Implants BV Zernikedreef 6 2333 CL Leiden The Netherlands
Re: K050357
R050337
Trade/Device Name: CAMCERAM TCP Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 14, 2005 Received: February 14, 2005
Dear Mr. Kuipers:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) prematice is substantially equivalent (for the indications referenced above and nave uctchimical the devices marketed predicate devices marketed in interstate for use stated in the enclosure, to regally manced prouther and the Federal Food. Food Drug commerce prior to May 28, 1970, the enaement auto of the Federal Food. Drug, devices that have been reclassified in accerative what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket of the Act, and Cosment Act (Act) that to not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the devreet, belyer to the go
general controls provisions of the Act include requirements for annual registration, and general controls provisions of the rectments of the received in the branding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) inlove in the existing your device can
may be subject to such additional controls. Existing major regulation EDA may may be subject to such additional controls. Existing major of 998. hr addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Feach. Feegaring your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualitat equires with other requirements of the Act
that FDA has made a determination that your device and concension - You must that FDA has made a decemination that your administered by other Federal agencies. You must or any Federal statutes and regulations daminders on registration and listing (21
comply with all the Act's requirements, including, but not limited to: returnments as set comply with an the Act s requirements, mercements are many of course requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing and if continently, the CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Party 21 CFR 1000 (1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Mr. Rutger Kuipers
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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stipt Rurdy
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: CAMCERAM TCP Bone Void Filler
Indications for Use:
CAMCERAM TCP is a bone void filler is a resorbable implant intended to fill bony void 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.
Prescription Use _ X__________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 subpart D) AND/OR
Over-The-Counter Use (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)
Stupt Rlurlu
(Divisio Division of General, Restorative. and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________