(209 days)
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No
The summary describes a bone void filler material and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is intended to fill bony voids or gaps resulting from injury or surgery and is replaced by host bone, indicating a therapeutic purpose of aiding in healing and restoring skeletal integrity.
No
Explanation: The device is a bone void filler intended for filling bony voids or gaps, not for diagnosing medical conditions.
No
The device description clearly states that PLEXUR P is a bone void filler containing processed human allograft bone tissue and a resorbable polymer, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of PLEXUR P is to fill bony voids or gaps in the skeletal system. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a bone void filler made of processed human allograft bone tissue and a resorbable polymer. It is implanted into the body.
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a condition, analyze samples from the body (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. PLEXUR P does not fit this description.
N/A
Intended Use / Indications for Use
“PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, 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 is resorbed/remodeled and is replaced by host bone during the healing process.”
Product codes
MBP, MQV
Device Description
PLEXUR P is a 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 a bone void filler in bony voids or gaps of the skeletal system (i.e., extremities, pelvis) not intrinsic to the stability of the bony structure. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skeletal system (i.e., extremities, pelvis)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The results of studies in animals showed that PLEXUR P supports bone ingrowth and new bone formation.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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VI. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Jan. 31. 2007
7 2007 FEB
- 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 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 a 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 a bone void filler in bony voids or gaps of the skeletal system (i.e., extremities, pelvis) not intrinsic to the stability of the bony structure. 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., extremities, 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 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, as does one or more of the predicate devices. PLEXUR P 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 P is provided ready-touse in various forms that can be cut or shaped by the user into various shapes or sizes.
7. Performance Data
The results of studies in animals showed that PLEXUR P supports bone ingrowth and new bone formation.
8. 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.
2
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 symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle symbol is composed of three curved lines that form the shape of an eagle's head and wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Osteotech, Incorporated c/o Mr. Christopher W. Talbot Director of Regulatory Affairs 51 James Way Eatontown, New Jersey 07724
7 2007 FEB
Re: K061982
Trade Name: Plexur P Regulation Number: 21 CFR 888:3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: November 17, 2006 Received: November 20, 2006
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, 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 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.
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Page 2 – Mr. Christopher W. Talbot
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.
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 Office of Compliance at (240) 276-0120. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Muchw
Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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V. Indications for Use - Statement
510(k) Number (if known): K061982
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., extremities, 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 is resorbed/remodeled and is replaced by host bone during the healing process.
Prescription Use × (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)
Barbara Melum
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061982