(317 days)
Not Found
No
The device description and intended use focus on the material properties and biological function of a bone void filler, with no mention of AI or ML technologies.
Yes
Explanation: The device is intended for filling bony voids or gaps in the skeletal system to aid in the healing process, which is a therapeutic function.
No
Explanation: The device, COLLOSS E, is described as a bone void filler intended for use in "filling bony voids or gaps of the skeletal system." Its function is to be resorbed and replaced by bone during healing. This is a therapeutic or reparative function, not a diagnostic one. There is no mention of it being used to detect, identify, or monitor medical conditions.
No
The device description clearly states that COLLOSS E is a physical bone void filler material extracted from equine bone, supplied as a lyophilizate in a collagenous matrix. It is a tangible product, 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 COLLOSS E is for "filling bony voids or gaps of the skeletal system." This is a therapeutic and structural application within the body.
- Device Description: The description details a bone void filler made from equine bone, intended to be implanted and resorbed. This is a medical device used for treatment, not for testing samples outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
Therefore, COLLOSS E is a medical device used for surgical intervention and bone repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
COLLOSS E is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. COLLOSS E is resorbed and replaced with bone during the healing process.
Product codes
MQV
Device Description
COLLOSS E is a bone void filler extracted from the extracellular n diaphyseal equine bone. It is a lyophilizate in collagenous matrix form, consisting of collagen Type I chains with other insoluble proteins present.
COLLOSS E is dry with a cotton-like appearance, having a white to slightly yellowish color. The product is processed under aseptic conditions and is nonpyrogenic. It is supplied in a 20 mg quantity, packaged in a vial inside of a Tyvek pouch. The inner surfaces of the pouch are terminally sterilized by plasma sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (e.g., the spine, pelvis, ilium, and/or extremities)
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 performance standards have been established for this type of device. The results of animal testing demonstrated that COLLOSS E is suitable for use as a bone void filler. It has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K042305, K050416, K012751, K043308, K043420, K043421, K031399
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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2006 MAR 8
Image /page/0/Picture/1 description: The image shows the word "OSSACUR" in a bold, sans-serif font, with a thick, curved line above and below the word. Below the word, there is a handwritten code "K051047". The code is written in a simple, legible style. The image is black and white.
510(K) Summary
- A. Submitter Information
| Submitter's Name: | OSSACUR® AG |
|---|---|
| Address: | Benzstrasse 2 |
| D-71720 | |
| Oberstenfeld, Germany | |
| Phone Number: | (+49) 7062 9404-0 |
| Fax Number: | (+49) 7062 9404-20 |
| Contact Person: | Arne Briest |
| Date of Preparation: | April 21, 2005 |
- B. Device Name
| Trade Name: | COLLOSS™ E |
|---|---|
| Common/Usual Name: | Bone Void Filler |
| Classification Name: | Resorbable calcium salt bone void filler device |
| §888.3045 (Product Code: MQV) |
- C. Predicate Devices
| Trade Name: | OSSAPLAST TM ORTHO Bone Void Filler
(K042305/K050416) |
|-------------|----------------------------------------------------------------------|
| Trade Name: | HEALOS® II Bone Graft Substitute
(K012751/K043308) |
| Trade Name: | Osteofil® DBM (K043420/K043421) |
| Trade Name: | InterGro® DBM (K031399) |
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Image /page/1/Picture/0 description: The image shows the word "OSSACUR" in a stylized font. The word is positioned between two curved lines that form the top and bottom of a circle. The font is bold and the letters are evenly spaced.
D. Device Description
COLLOSS E is a bone void filler extracted from the extracellular n diaphyseal equine bone. It is a lyophilizate in collagenous matrix form, consisting of collagen Type I chains with other insoluble proteins present.
COLLOSS E is dry with a cotton-like appearance, having a white to slightly yellowish color. The product is processed under aseptic conditions and is nonpyrogenic. It is supplied in a 20 mg quantity, packaged in a vial inside of a Tyvek pouch. The inner surfaces of the pouch are terminally sterilized by plasma sterilization.
E. Intended Use
COLLOSS E is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. COLLOSS E is resorbed and replaced with bone during the healing process.
F. Technological Characteristics Summary
COLLOSS E was characterized in accordance with ASTM F 2212-02: Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPS). The product description information and characterization data in conjunction with the device labeling demonstrate substantial equivalence to the predicate devices.
G. Performance Data
No performance standards have been established for this type of device. The results of animal testing demonstrated that COLLOSS E is suitable for use as a bone void filler. It has been designed and manufactured to perform in a manner substantially equivalent to that of the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2006
OSSACUR AG c/o Pacific OtterWorks, Inc. Ms. Kristi Kistner, RAC President 975 Veronica Springs Road Santa Barbara, California 93105
Re: K051047/S1
Trade/Device Name: COLLOSS™ E 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: September 16, 2005 Received: September 19, 2005
Dear Ms. Kistner:
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. Isting 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. Tixisting major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. I 1 ) V may publish further announcements concerning your device in the Federal Register
Please be advised that FDA is issuance of a substantial equivalence determination does no 1000 that FDA has made a determination that your device complies with other requirements of the he 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 - Ms. Kistner
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 (TFR 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,
Herbert Lewin
Mark N. Melkerson Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION I-E.
Statement of Indications for Use
510(k) Number (if known):
Device Name: COLLOSS™ E Bone Void Filler
Indications for Use:
COLLOSS E is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. COLLOSS E is resorbed and replaced with bone during the healing process.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hele Luvin is
Division Sign-Off)
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K051047
OSSACUR® AG
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