(83 days)
PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e. 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 created from traumatic injury to the bone. In addition, Plexur M may be used in conjunction with autograft as a bone void filler in the spine. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.
PLEXUR M is a bone void filler product that contains, as a key constituent, processed human bone particles that are mixed with resorbable/biodegradeable non-tissue components. It is intended to be heated at the time of use, whereupon it becomes moldable, thus allowing the surgeon to pack it into the implant site or shape it to accommodate variations in the geometry and size of the particular implant site. As it cools down, the PLEXUR M returns to its normal hardened/rigid state and remains this way at body temperature. The surgeon may further shape, cut or grind PLEXUR M in the hardened state using conventional surgical instruments. PLEXUR M is packaged/provided for single use in a sterile form. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process. A compact, single use heater is available as a means to heat the PLEXUR M at the time of use to make it pliable. Alternatively, PLEXUR M may be heated in a water bath.
The provided document, K081227, is a 510(k) summary for the PLEXUR M bone void filler. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing robust performance criteria through comprehensive clinical trials as might be seen for novel devices.
Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through a comparison to predicate devices and animal study results. There are no explicit quantitative acceptance criteria or detailed human-based performance metrics in this summary.
Here's an analysis based on the provided text, addressing your points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility and absence of adverse reactions | Implied by substantial equivalence to predicate devices and the processing steps for viral inactivation. "PLEXUR M is packaged/provided for single use in a sterile form." "In the production of PLEXUR M, the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis B and C and CMV." |
| Effectiveness: Support of bone in-growth and new bone formation | "The results of studies in animal showed that PLEXUR M supports bone in-growth and new bone formation to an extent at a rate at least comparable to predicate devices." |
| Bioremodeling: Resorption and replacement by host bone | "PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process." (Stated as an intended mechanism of action, implicitly supported by substantial equivalence and animal studies). |
| Functional Equivalence: Handling and mechanical properties | "PLEXUR M is substantially equivalent to one or more of the predicate devices with respect to materials." "PLEXUR M contains human allograft bone tissue, as does one or more of the predicate devices." "PLEXUR M also contains resorbable polymer of the same type as those in one or more of the predicate devices." "Also, like one or more of the predicate devices, PLEXUR M is provided sterile in various sizes that, upon heating (using a compact, single use sterile heater to be marketed by Osteotech), it is made moldable and can be cut or shaped by the user into various shapes or sizes. It may be further shaped by the surgeon in its hardened state using conventional surgical instruments." This implies similar handling characteristics and the ability to fill voids. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "studies in animal" without providing the number of animals or specific details of the study design.
- Data Provenance: The studies were conducted in "animal," indicating an animal model. The country of origin is not specified. The study is described retrospectively in the 510(k) summary (i.e., the results are being reported).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was an animal study focused on histological and biological endpoints, not human expert interpretation of images for diagnosis.
4. Adjudication Method for the Test Set
Not applicable. As described above, it was an animal study, not a study requiring human adjudication for diagnostic ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study (MRMC for human readers with and without AI assistance) is not applicable to an animal study for a bone void filler product demonstrating substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The performance data presented refers to the inherent biological and structural properties of the PLEXUR M device itself in an animal model, without direct human intervention in the assessment process, beyond standard pathological evaluations. It's not an "algorithm-only" study in the context of AI, but rather an evaluation of the device's biological function.
7. The Type of Ground Truth Used
- Animal Study for Biological Response: The "ground truth" was established through direct observation and histological analysis of bone in-growth and new bone formation in the animal model. This is akin to pathology/histology and direct biological observation.
8. The Sample Size for the Training Set
Not applicable. This product is a medical device (bone void filler), not an AI algorithm. There is no concept of a "training set" in the context of its development as described here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
Summary of the Study Proving Acceptance:
The study referenced is an animal study that demonstrated the PLEXUR M device supports bone in-growth and new bone formation. The acceptance criteria were implicitly set by demonstrating that this biological performance was "at least comparable to predicate devices." The data provenance is an unspecified animal model, and the ground truth was established by direct observation and analysis of biological response (e.g., histology). No human-reader or AI-specific studies were conducted or reported in this 510(k) summary. The primary method of establishing "acceptance" for a 510(k) device like this is through the demonstration of substantial equivalence to previously cleared predicate devices, supported by non-clinical (e.g., animal, bench) or, if necessary, clinical data.
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7.0 510 (K) Summary of Safety and Effectiveness
July 14, 2008
-
- Submission Applicant & Correspondent:
IJUL 2 2 2008
- Submission Applicant & Correspondent:
| Name: | Osteotech, Inc. |
|---|---|
| Address: | 51 James Way |
| Eatontown, NJ 07724 | |
| Phone No.: | (732) 542-2800 |
| Contact Person: | Chris Talbot |
-
- Name of Product:
| Trade/Proprietary/Model Name: | PLEXUR M ™ |
|---|---|
| Common or Usual Name: | Bone Void Filler |
| Classification Name: | Resorbable Bone Void Filler |
-
- Devices to Which New Product is Substantially Equivalent:
PLEXUR M 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 M is a bone void filler product that contains, as a key constituent, processed human bone particles that are mixed with resorbable/biodegradeable non-tissue components. It is intended to be heated at the time of use, whereupon it becomes moldable, thus allowing the surgeon to pack it into the implant site or shape it to accommodate variations in the geometry and size of the particular implant site. As it cools down, the PLEXUR M returns to its normal hardened/rigid state and remains this way at body temperature. The surgeon may further shape, cut or grind PLEXUR M in the hardened state using conventional surgical instruments.
- Device Description:
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PLEXUR M is packaged/provided for single use in a sterile form. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process. A compact, single use heater is available as a means to heat the PLEXUR M at the time of use to make it pliable. Alternatively, PLEXUR M may be heated in a water bath.
5. Intended Use/Indications
PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e. 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 created from traumatic injury to the bone. In addition, Plexur M may be used in conjunction with autograft as a bone void filler in the spine. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.
6. Technical Comparison
PLEXUR M is substantially equivalent to one or more of the predicate devices with respect to materials. PLEXUR M contains human allograft bone tissue, as does one or more of the predicate devices. PLEXUR M also contains resorbable polymer of the same type as those in one or more of the predicate devices. Also, like one or more of the predicate devices, PLEXUR M is provided sterile in various sizes that, upon heating (using a compact, single use sterile heater to be marketed by Osteotech), it is made moldable and can be cut or shaped by the user into various shapes or sizes. It may be further shaped by the surgeon in its hardened state using conventional surgical instruments.
7. Performance Data
The results of studies in animal showed that PLEXUR M supports bone in-growth and new bone formation to an extent at a rate at least comparable to predicate devices.
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K081227 (pg. 3 of 3)
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- Viral Inactivation
In the production of PLEXUR M, 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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osteotech, Inc. % Mr. Chris Talbot 51 James Way Eatontown, NJ 07724
JUL 2 2 2008
Re: K081227 Trade/Device Name: PLEXUR MTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: April 29, 2008 Received: April 30, 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). 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. Iisting 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 - 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 M. Millen
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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5.0 Indications for Use Statement
K081227 510(k) Number: Device Name; PLEXUR M
Indications for Use: PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e. 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 created from traumatic injury to the bone. In addition, Plexur M may be used in conjunction with autograft as a bone void filler in the spine. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.
| Prescription Use | X |
|---|---|
| (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)
Saubare buentp
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Division of General. Restorative. and Neurological Devices
510(k) Number K081227
§ 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.