(18 days)
OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Ostene®CT is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.
Ostene®CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. * Ostene® CT contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.
As a bone hemostasis agent, Ostene®CT stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene®CT is provided sterile by irradiation and must not be resterilized. * A substitution has been made in a neutral excipient copolymer.
This submission describes a medical device, Ostene®CT, which is a bone hemostasis implant material. The document provided is primarily a 510(k) summary for a Special 510(k) submission, indicating a modification to an already legally marketed device. Therefore, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report typical for novel devices.
Given the nature of a Special 510(k) and the provided text, there is no specific performance study with defined acceptance criteria in the way one might expect for a new, high-risk device requiring detailed clinical trial data. The device is for bone hemostasis and is classified as "Unclassified," which typically means less stringent performance study requirements for demonstrating substantial equivalence, especially when it's a modification of a predicate.
The primary "study" is the demonstration that a "substitution has been made in a neutral excipient copolymer" and that the modified Ostene®CT "has the same intended use and fundamental scientific technology as the legally marketed Ostene®CT Soluble Bone Hemostasis Implant."
Here's an attempt to answer your questions based on the provided text, noting where specific information is absent due to the type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a Special 510(k) for a modified device, the "acceptance criteria" are generally that the modified device remains substantially equivalent to the predicate device and that the change (a neutral excipient copolymer substitution) does not adversely affect safety or effectiveness. Specific numerical performance targets are not provided in the document for the new Ostene®CT against the predicate.
| Acceptance Criteria (Implied for Special 510(k)) | Reported Device Performance (Summary) |
|---|---|
| Same intended use as predicate | Ostene®CT has the "same intended use." |
| Same fundamental scientific technology as predicate | Ostene®CT has the "same fundamental scientific technology." |
| No new questions of safety or effectiveness | Not explicitly stated as a separate finding, but implied by 510(k) clearance. The modification is a "neutral excipient copolymer." |
| Effective in controlling bone bleeding | As a bone hemostasis agent, it "stops bone bleeding by the creation of a physical barrier... This plug prevents further bleeding." (This is a description of its mechanism, not a quantified performance measure from a new study against acceptance criteria). |
| Sterile by irradiation | Provided "sterile by irradiation." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. Clinical trial data with defined sample sizes and test sets are not presented in this 510(k) summary. The submission focuses on the modification of an excipient in an already cleared device.
- Data Provenance: Not applicable in the context of a performance study; the submission details the device composition and its mechanism of action, emphasizing its similarity to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no mention of a clinical "test set" requiring ground truth established by experts in this 510(k) summary.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This device is a bone hemostasis implant material, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done
- Not applicable. This device is a physical implant material, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable in the context of a typical performance study for diagnostic AI or imaging devices. For a medical device like this, "ground truth" often relates to established scientific principles of material compatibility and physiological function, as well as pre-clinical testing (e.g., biocompatibility, hemostatic efficacy in animal models), which are standard for medical device development but not detailed in this 510(k) summary. The primary "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set."
Summary based on the document:
This 510(k) submission for Ostene®CT is for a modified version of an already cleared device. The "study" proving it meets acceptance criteria is primarily the demonstration of substantial equivalence to the predicate device (Ceremed, Inc. Ostene® Soluble Bone Hemostasis Implant Material, K082491), especially considering a "substitution has been made in a neutral excipient copolymer." The acceptance criteria are implicitly met if the FDA determines that the modified device has the same intended use, fundamental scientific technology, and does not raise new questions of safety or effectiveness compared to the predicate. Details on specific performance metrics, sample sizes, or expert adjudication for clinical performance studies are not provided in this regulatory summary.
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K09636
Ceremed. Inc. Special 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
IX - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Submitted by:
JUN 22 2009
Page 9
Tadeusz Wellisz, M.D. Ceremed, Inc. 3643 Lenawee Ave. Los Angeles, California 90016 Tel: (310) 815-2125 Fax: (310) 815-2130
Contact Person:
Date Prepared
Common/Usual Name:
Proprietary Name:
Regulatory Class:
Classification Name:
Product Code:
Predicate Device:
Tadeusz Wellisz, M.D.
June 1, 2009
Soluble Bone Hemostasis Implant Material
Ostene®CT, AOC™CT, Osteotene™, Ceretene
Unclassified
Wax, Bone
MTJ
Ceremed, Inc. Ostene® Soluble Bone Hemostasis Implant Material (K082491)
Description of the device:
Ostene®CT is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.
Ostene®CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. * Ostene® CT contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.
As a bone hemostasis agent, Ostene®CT stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene®CT is provided sterile by irradiation and must not be resterilized. * A substitution has been made in a neutral excipient copolymer.
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K091636 Page 7/2
Ceremed, Inc. Page 9 - 2 Special 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
Intended use:
Ostene®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Substantial equivalence:
The modified Ostene®CT Soluble Bone Hemostasis Implant has the same intended use and fundamental scientific technology as the legally marketed Ostene®CT Soluble Bone Hemostasis Implant.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines or strokes.
Public Health Service
JUN 22 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ceremed, Inc. % Tadeusz Wellisz, M.D. Chairman 3643 Lenawee Avenue Los Angeles, California 90016
Re: K091636
Trade/Device Name: Ostene®CT, AOC™CT, Osteotene™, Ceretene™ Regulatory Class: Unclassified Product Code: MTJ Dated: June 1, 2009 Received: June 4, 2009
Dear Dr. Wellisz:
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 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); medical device reporting (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.
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Page 2 - Tadeusz Wellisz, M.D.
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milken
Mark N.Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ceremed, Inc.
Special 510 (k) - Ostene®CT Soluble Bone Hemostasis Implant Material
VII. INDICATIONS FOR USE:
510 (k) Number (if known): Kog (1 (236
Device Name: Ostene®CT, AOC™CT, Osteotene™, Ceretene™
Indications For Use:
OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)
CONCURRANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Daniel Krone for MXM
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091636
Division Sign-Off
510(k) Number
N/A