(56 days)
PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., spine, pelvis and 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. Plexur P may also be used as a bone graft extender in the spine. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.
PLEXUR P is bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. Plexur P mav also be used as a bone graft extender in the spine. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.
The provided text describes the 510(k) summary for the PLEXUR P bone void filler. It indicates that the device has been found substantially equivalent to predicate devices based on certain performance data. However, the document does not include specific acceptance criteria, nor does it detail a study with quantitative results that definitively "proves" the device meets such criteria in the way a clinical trial or a statistically powered non-inferiority study would.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or provide a table of performance metrics. The core of the performance evaluation is based on a comparative, rather than absolute, standard against predicate devices.
| Acceptance Criteria (Not Explicitly Stated, Inferred) | Reported Device Performance |
|---|---|
| Support bone in-growth comparable to predicate devices | PLEXUR P supports bone in-growth to an extent at a rate at least comparable to predicate devices. |
| Support new bone formation comparable to predicate devices | PLEXUR P supports new bone formation to an extent at a rate at least comparable to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states "studies in animal" but does not specify the number of animals or the overall sample size used in these studies.
- Data Provenance: The studies were conducted "in animal." No country of origin is mentioned, and it is implied to be prospective animal studies, not retrospective human data.
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)
This information is not provided. The animal studies would likely involve veterinary pathologists or researchers assessing bone healing, but no details are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
No such study was conducted. This device is a bone void filler, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the animal studies would have been based on biological and histological assessments of bone in-growth and new bone formation, likely through techniques such as histology, histomorphometry, and potentially imaging of the bone healing process. This would fall under pathology/biological outcomes in animal models.
8. The sample size for the training set
This is not applicable as the device is an implant and does not involve machine learning or a training set in the typical sense.
9. How the ground truth for the training set was established
This is not applicable as the device is an implant and does not involve machine learning or a training set.
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VII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Mar. 31. 2008
-
- Submission Applicant & Correspondent:
APR 2 1 2008
- Submission Applicant & Correspondent:
| Name: | Osteotech, Inc. |
|---|---|
| Address: | 51 James Way |
| Eatontown, NJ 07724 | |
| Phone No .: | (732) 542-2800 |
| Contact Person: | Chris Talbot |
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- Name of Product:
| Trade/Proprietary/Model Name: | PLEXUR P |
|---|---|
| Common or Usual Name: | Bone Void Filler |
| Classification Name: | Resorbable Bone Void Filler |
-
- Devices to Which New Product is Substantially Equivalent:
PLEXUR P is substantially equivalent, for the purpose of this 510(k), to other devices that have received 510(k) clearance for similar indications for use.
- Devices to Which New Product is Substantially Equivalent:
-
- Device Description:
PLEXUR P is bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. Plexur P mav also be used as a bone graft extender in the spine. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.
- Device Description:
-
- Intended Use/Indications
PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., spine, extremities, and pelvis) 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. Plexur P may also be used as a bone graft extender in the spine. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.
- Intended Use/Indications
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6. Technical Comparison
PLEXUR P is substantially equivalent to one or more of the predicate devices with respect to materials. PLEXUR P contains human allograft bone tissue and polymer that are resorbed and/or remodeled into new host bone. The predicate devices also contain materials that are resorbed and /or remodeled into new host bone. Moreover, like the predicate devices, PLEXUR P is provided ready-to-use in various forms that can be cut or shaped by the user into various shapes or sizes.
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- Performance Data
The results of studies in animal showed that PLEXUR P supports bone in-growth and new bone formation to an extent at a rate at least comparable to predicate devices.
- Performance Data
-
- Viral Inactivation
In the production of Plexur P, the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis B and C and CMV.
- Viral Inactivation
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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 stylized eagle with three stripes extending from its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osteotech, Inc. % Mr. Chris Talbot Director, Regulatory Affairs 51 James Way Eatontown, NJ 07724
APR 2 1 2008
Re: K080511
Trade/Device Name: PLEXUR P Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: February 22, 2008 Received: February 25, 2008
Dear Mr. Talbot:
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). and coosine . For ( roy ) rest the device, subject to the general controls provisions of the Act. The r ou may, attrefere, missions 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has Intact a and regulations administered by other Federal agencies. You must or any I oderal states and see and see and the best he 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 – Mr. Chris Talbot
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 V.
K080511 510(k) Number (if known):_
Device Name: PLEXUR P
Indications for Use:
PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., spine, pelvis and 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. Plexur P may also be used as a bone graft extender in the spine. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden facnxm
Division of General, Restorative, and Neurological Devices
510(k) Number K080511
§ 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.