(56 days)
Cerasorb® M ORTHO (polygonal broken morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (e.g. extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.
The device modification is a change in the shape resp. size of the bone void filler. The predicate device Cerasorb® ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as polygonal shaped morsels of different sizes ranging from 50 8000m. The pure phase Beta-Tricalcium Phosphate material is of interconnecting microporosity and additionally contains defined interconnecting meso-, and macropores (50 - 500 um).
This appears to be a 510(k) premarket notification for a medical device (Cerasorb® M ORTHO). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing a separate study to prove the device meets specific acceptance criteria in the way a new, novel AI/software device would. Therefore, most of the requested information about acceptance criteria and a study proving performance isn't applicable in this context.
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance
Not applicable in this document. This submission is for a material modification (shape/size) of an existing bone void filler. The "acceptance criteria" here are based on demonstrating substantial equivalence to existing predicate devices, primarily in terms of material composition, intended use, and general performance characteristics. The document doesn't report specific performance metrics or acceptance thresholds for a new study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. There is no "test set" in the context of proving new performance claims. The submission focuses on the material's properties (Beta-Tricalcium Phosphate composition, porosity) and intended use, which are compared to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no test set requiring expert ground truth in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. 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/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the established safety and efficacy of the predicate devices and the chemical/physical properties of the material itself (Beta-Tricalcium Phosphate with interconnecting porosity, osteoconductive, resorbable). The document states the material conforms to ASTM F 1088-87, reapp. 1992.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/software device or a de novo submission requiring extensive new clinical data.
9. How the ground truth for the training set was established
Not applicable.
Summary of what the document does provide regarding "acceptance":
The "acceptance" in this 510(k) submission is based on the FDA's determination of substantial equivalence to legally marketed predicate devices. Key aspects considered for this determination include:
- Identical Intended Use: The intended use of Cerasorb® M ORTHO (morsels) is explicitly stated and compared to the predicate device, Cerasorb® ORTHO (granular form), and other similar bone void fillers. Both are for use as bone void fillers in voids/gaps in the skeletal system not intrinsic to stability, to be gradually resorbed and replaced by bone.
- Similar Technological Characteristics:
- Material Composition: Both the modified device and the predicate are stated to consist of "pure phase Beta-Tricalcium Phosphate ceramic material according to ASTM F 1088-87, reapp. 1992." This is the primary claim for material similarity.
- Porosity: Both are described as having interconnecting porosity, osteoconductive, and resorbable properties. The modified device specifically mentions interconnecting micro-, meso-, and macropores.
- Functionality: Both are designed to be bone void fillers that are gradually resorbed and replaced by bone.
- Safety and Effectiveness: By demonstrating substantial equivalence to legally marketed predicate devices, the submission implicitly claims similar safety and effectiveness without needing a new, comprehensive clinical trial for this specific modification. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."
In essence, for this type of submission (line extension/modification of an existing material), the "acceptance criteria" revolve around proving that the minor change (shape/size) does not alter the fundamental safety or effectiveness parameters established by the predicate devices. The study proving this is the 510(k) submission itself, which provides a comparative analysis to the predicate devices.
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March 12, 2004
MAR 2 6 2004
Image /page/0/Picture/2 description: The image shows a handwritten text string "K040216" on the top line. Below the first line, there is another line of text that reads "9-1". The text appears to be written in black ink on a white background.
Image /page/0/Picture/3 description: The image shows the word "curasan" in a bold, sans-serif font. The letters are black and appear to be slightly curved along the bottom edge. The word is presented in a simple, straightforward manner, with no additional design elements or background distractions.
Special 510 (K) Summary: Line Extension to Cerasorb® ORTHO (granular form)
Submission Information:
| Name and Addressof the Sponsor: | curasan AGLindigstrasse 463801 KleinostheimGermany |
|---|---|
| Contact person: | Stefan MeinersHead of Regulatory Affairs and Quality ManagementTel.: ++49 - 6027 - 4686-94Fax: ++49 - 6027 - 4686-33E - Mail: stefan.meiners@curasan.de |
| Registered U. S. agent: | Dr. Eric Wiechert109 Shore DriveGarner, NC 27529USAPhone: 919 - 772-8518, fax: 919 - 772-1300E - Mail: ewiecher@bellsouth.net |
Device Identification:
| Proprietary Name: | Cerasorb® M ORTHO |
|---|---|
| Common Name: | Bone Void Filler |
| Classification: | Class II |
Predicate Devices:
| Cerasorb® ORTHO (granular form): Bone void filler consisting of pure phaseBeta-Tricalcium Phosphate. | |
|---|---|
| Cerasorb® ORTHO (block forms): Bone void filler, block forms consisting of purephase Beta-Tricalcium Phosphate | |
| Vitoss Scaffold Synthetic: | Bone void filler, granules, block forms and morselsconsisting of Beta-Tricalcium Phosphate |
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Description of the Device Modification:
The device modification is a change in the shape resp. size of the bone void filler. The predicate device Cerasorb® ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity.
This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as polygonal shaped morsels of different sizes ranging from 50 8000m. The pure phase Beta-Tricalcium Phosphate material is of interconnecting microporosity and additionally contains defined interconnecting meso-, and macropores (50 - 500 um).
Intended Use:
Cerasorb® M ORTHO (morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.
Statement of technological comparison
All design modifications consist of pure phase Beta-Tricalcium Phosphate ceramic material according to ASTM F 1088-87, reapp. 1992. The material is of interconnecting porosity, osteoconductive and resorbable.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2004
Curasan AG C/o Eric Wiechert, Ph.D., RAC President Applications Specialists International, Inc. 109 Shore Drive Garner. North Carolina 27529
Re: K040216
Trade/Device Name: Cerasorb® M ORTHO Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: March 12, 2004 Received: March 18, 2004
Dear Dr. Wiechert:
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 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.
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Page 2 - Eric Wiechert, Ph.D., RAC
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Milkman
Celia M. Witten, PhD. MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040216
Cerasorb® M ORTHO Device Name:
Indications for Use:
Cerasorb® M ORTHO (polygonal broken morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (e.g. extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number кон 0216
§ 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.