(14 days)
OSTENE® is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Ostene 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 is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. Ostene 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 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, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene is provided sterile by irradiation and must not be resterilized.
This document is a 510(k) submission for the Ceremed, Inc. AOC Bone Wax (marketed as Ostene®). It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets acceptance criteria.
The 510(k) summary (page 9-1 and 9-2) explicitly states: "The modified Ostene® Bone Hemostasis Material has the same intended use fundamental scientific technology as the legally marketed Ostene® Bone Hemostasis Material." This indicates that the submission relies on the substantial equivalence principle, asserting that the new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical or performance data for acceptance criteria.
Therefore, I cannot populate the table or answer most of the questions as the provided text does not describe a study.
Here's what can be inferred from the provided text:
1. A table of acceptance criteria and the reported device performance:
Not provided in the document. The submission claims substantial equivalence and does not detail specific performance acceptance criteria or report results from a study designed to meet such criteria.
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. No new study data is presented.
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. No new study data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No new study data is presented.
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 device is a bone hemostasis material, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a bone hemostasis material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new study data is presented.
8. The sample size for the training set:
Not applicable. No new study data is presented.
9. How the ground truth for the training set was established:
Not applicable. No new study data is presented.
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Ko70093 Page 1/2
Ceremed. Inc. AOC Bone Wax 510 (k) Submission
Page 9 - 1
IX - 510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Submitted by:
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:
Classification Name:
Predicate Device:
JAN 2 4 2007
Tadeusz Wellisz, M.D. January 8, 2007
Bone Hemostasis Implant Material
Ostene®, AOC™, Osteotene™. Ceretene™, Cerepor™, Aptene™ Apatene™, Actipaste
Bone Wax (Unclassified) ENT Synthetic Polymer Material (Class II)
Ceremed, Inc. Ostene® Bone Hemostasis Material K062280
Description of the device:
Ostene 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 is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. Ostene 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 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, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.
Ostene is provided sterile by irradiation and must not be resterilized.
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K070093 page 2/2
Ceremed, Inc. AOC Bone Wax 510 (k) Submission
Page 9 - 2
Intended use:
OSTENE 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® Bone Hemostasis Material has the same intended use fundamental scientific technology as the legally marketed Ostene® Bone Hemostasis Material.
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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 its wings spread, rendered in black. The eagle is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ceremed Inc. % Tadeusz Wellisz, M.D. President 3643 Lenawee Avenue Los Angeles, California 90016
JAN 2 4 2007
Re: K070093
Trade/Device Name: Ostene ® Soluble Bone Hemostasis Implant Material, AOC™, Ostene™. Osteotene"", Ceretene"", Cerepor™, Aptene™, Apatene™ Actipaste Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: KHJ, MTJ Dated: January 8, 2007 Received: January 10, 2007
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 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, CDA ear 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 not 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 – Tadeusz Wellisz, M.D.
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 I ogally 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) 276-0115. 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 a mall 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/cdrhindustry/support/index.html.
Sincerely yours,
Ron Melkersoh
Mark N. Melkersoh
Mark N. Melkersoh Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
VII. INDICATIONS FOR USE:
510 (k) Number (if known): K070093
Device Name: Ostene® Soluble Bone Hemostasis Implant Material, AOC™, Ostene™ Osteotene™, Ceretene™, Cerepor™, Aptene™, Apatene™, Actipaste
Indications For Use:
OSTENE® is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
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
510(k) Number lc070093
Page 1 of
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.