(113 days)
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
OSferion is a white porous material composed of ß-tricalcium phosphate(ß-TCP). It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSfenon is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The OSferion product range consists of two product types with porosities of 75% and 60%. Products are supplied in blocks, cylinders, granules and wedges.
This 510(k) summary (K080065) is for a medical device called "OSferion," which is a bone void filler. This submission does not refer to a study evaluating a device with AI/ML technology. Instead, it is a premarket notification for a traditional medical device, comparing it to predicate devices already on the market. Therefore, many of the requested categories related to AI/ML device studies are not applicable.
Here's the breakdown of the information that can be extracted from the provided text, and where the information is not available due to the nature of the device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a conventional medical device (bone void filler) based on substantial equivalence, there are no specific quantitative "acceptance criteria" for an AI model's performance (like sensitivity, specificity, AUC) outlined in this document as there would be for an AI/ML diagnostic or prognostic device. The acceptance is based on demonstrating substantial equivalence to predicate devices, focusing on materials, indications for use, and mechanism of action.
| Acceptance Criteria (from a traditional device perspective) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|
| Indications for Use: To be gently packed or placed into bony voids or gaps of the skeletal system (extremities, spine, pelvis) that are not intrinsic to structures stability. Scaffold resorbs and is replaced by bone. | OSferion's Indications for Use are "basically identical" to predicate devices. |
| Material Composition: B-tricalcium phosphate (B-TCP). | OSferion is composed of B-tricalcium phosphate (B-TCP). |
| Biological Function: Bone replacement material, allowing replacement by autogenous bone after implantation. | Has properties that allow it to be replaced by autogenous bone after implantation. |
| Safety and Efficacy: Supported by clinical literature. | The clinical literature provided in this submission supports the safety and efficacy of OSferion. |
| Technological Characteristics: Similar to predicate devices. | OSferion is "similar in specifications of the material" to predicate devices. |
| No Significant Changes Affecting Safety/Effectiveness: No changes in intended use, method of operation, material, or design that could affect safety or effectiveness compared to predicate. | Concluded that the device "does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. Since it's not an AI/ML device, there isn't a "test set" in the context of algorithm evaluation. The submission refers to "clinical literatures" to support safety and efficacy, but details about these studies (sample size, data provenance) are not present in this abstract.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable/not provided. As there is no AI/ML algorithm being evaluated, there is no "test set" requiring ground truth established by experts in this context. The evaluation is based on material properties, intended use, and comparison to legally marketed predicate devices.
4. Adjudication Method for the Test Set
This is not applicable/not provided.
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
This is not applicable. This submission is for a physical medical device (bone void filler), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI assistance would not have been performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. There is no algorithm being evaluated in this submission.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and efficacy of the predicate devices (Synthes chronoSTM and Vitoss® Scaffold) based on their regulatory approvals and clinical use. The "truth" for OSferion's acceptability is its substantial equivalence to these devices, which implies similar clinical performance. The submission states that "The clinical literatures provided in this submission supports the safety and efficacy of OSferion," indicating that past clinical data on similar materials/devices form the basis of the "truth."
8. The Sample Size for the Training Set
This is not applicable. There is no AI model, and thus no "training set" in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
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ੇ ਹੋ ਹੈ
510(k) SUMMARY
OSferion
MAY - 2 2008
November 30th, 2007
1 General Information
| Applicant: | OLYMPUS TERUMO BIOMATERIALS CORP.34-3 Hirai, Hinode-machi, Nishitama-gun,Tokyo 190-0182, JapanEstablishment Registration No:Active; awaiting assignment of registration number | |
|---|---|---|
| Official Correspondent: | Laura Storms-TylerRegulatory Affairs & Quality AssuranceOlympus America Inc.3500 Corporate ParkwayPO Box 610Center Valley PA18034-0610,Phone: (484) 896-5688Facsimile: (484) 896-7128Email:Laura.storms-tyler@olympus.comEstablishment Registration No: 2429304 | |
| ■ | Manufacturer:(Sterilization site) | OLYMPUS TERUMO BIOMATERIALS CORP.Hinode Factory34-3 Hirai, Hinode-machi, Nishitama-gun,Tokyo 190-0182, JapanEstablishment Registration No: |
2 Device Identification
| ■ | Device Trade Name: | OSferion |
|---|---|---|
| ■ | Common Name: | Bone void filler |
| ■ | Regulation Number: | 21 CFR 888.3045 |
| ■ | Regulation Name: | Resorbable calcium salt bone void filler device |
| ■ | Regulatory Class: | II |
| ■ | Classification Panel: | Orthopedic |
| ■ | Product Code: | MQV |
Active; awaiting assignment of registration number
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87 Predicate Device Information
| Predicate Device | |||
|---|---|---|---|
| Device Name: | Synthes (USA) chronOS ™ | Vitoss® ScaffoldSynthetic CancellousBone Void Filler | OSferion |
| Common Name: | Bone void filler | Bone void filler | Bone void filler |
| Manufacturer: | Synthes | Orthovita | OLYMPUS TERUMOBIOMATERIALSCORP. |
| 510(k) No. | K043045 | K032409 | K061499 |
4 Device Description
OSferion is a white porous material composed of ß-tricalcium phosphate(ß-TCP). It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSfenon is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation.
The OSferion product range consists of two product types with porosities of 75% and 60%. Products are supplied in blocks, cylinders, granules and wedges.
ട് Indications for Use
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
6 Comparison of Technological Characteristics
OSferion is basically identical to the predicate devices in indication for use, and is similar in specifications of the material.
The clinical literatures provided in this submission supports the safety and efficacy of OSferion.
7 Conclusion
When compared to the predicate device, this subject device "OSferion" does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
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Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Olympus Terumo Biomaterials Corporation % Olympus America Inc. Ms. Laura Storms-Tyler 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034
Re: K080065
Trade/Device Name: OSferion Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone filler device Regulatory Class: II Product Code: MQV Dated: April 24, 2008 Received: April 25, 2008
Dear Ms. Storms-Tyler:
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.
MAY - 2 2008
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 - Ms. Laura Storms-Tyler
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millican
Mark N. Melkerson 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 Statement
510(k) Number (if known): K040065
Device Name: OSferion
Indications for Use:
OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure.
Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
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)
Neil RP Ogden for man
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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K080065 510(k) Number_
§ 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.