CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON

• K Number: K072327
• Device Name: CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
• Manufacturer: REGENERATION TECHNOLOGIES, INC.
• Date Cleared: 2007-10-24 ( 65 days)
• Product Code: MQV , ORT
• Regulation Number: 888.3045
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

Device Description

The CANCELLO-PURE™ Wedge is machined into a wedge shape from bovine bone processed with the BioCleanse® Tissue Sterilization Process. These products are preshaped for surgeon convenience.

AI/ML Overview

Acceptance Criteria and Device Performance Study for CANCELLO-PURE™ Wedge

This document describes the acceptance criteria and the study that demonstrates the CANCELLO-PURE™ Wedge device meets these criteria, as presented in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Supporting Performance
Material Equivalence	Materials are substantially equivalent to predicate devices.	The CANCELLO-PURE™ Wedge is machined from bovine bone.	Stated as "materials... [are] equivalent to predicate devices" in the 510(k) summary.
Design Equivalence	Design is substantially equivalent to predicate devices.	The device is machined into a wedge shape from bovine bone.	Stated as "design... [is] equivalent to predicate devices" in the 510(k) summary.
Function Equivalence	Function is substantially equivalent to predicate devices.	Provides a void filler that remodels into the recipient's skeletal system.	Stated as "function... [is] equivalent to predicate devices" in the 510(k) summary.
Remodeling Capability	Capable of remodeling comparably to allograft.	Processed bovine bone (used in CANCELLO-PURE™ Wedge) shows comparable remodeling to allograft.	Animal model study.
Viral Inactivation	BioCleanse® process capable of reducing a panel of viruses to below detectable limits.	The BioCleanse® process achieved reduction of a panel of viruses to below detectable limits.	Viral inactivation study using a worst-case representation of the BioCleanse® process.

2. Sample Sizes and Data Provenance

• Test Set Sample Size:

  • Animal Model (Remodeling): Not explicitly stated. The document refers to "an animal model" without specifying the number of animals or cases.
  • Viral Inactivation Study: Not explicitly stated regarding sample size beyond "a panel of viruses."

• Data Provenance:

  • Animal Model (Remodeling): The document does not specify the country of origin. It is a prospective study as it involves an "animal model."
  • Viral Inactivation Study: The document does not specify the country of origin. It is a prospective study as it involved a "worst-case representation of the BioCleanse® process."

3. Number and Qualifications of Experts for Ground Truth

• Not Applicable. The provided document does not describe studies involving human medical image or diagnosis interpretation that would require expert adjudication for ground truth. The studies cited are an animal model and a viral inactivation study.

4. Adjudication Method for Test Set

• Not Applicable. As noted above, the studies do not involve human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC comparative effectiveness study was not done. The document does not describe studies evaluating human reader performance, either with or without AI assistance, or any comparison to human readers.

6. Standalone (Algorithm Only) Performance Study

• No. A standalone algorithm performance study was not mentioned. The device is a physical bone void filler, not an AI algorithm. The performance studies relate to the biological and safety characteristics of the physical product.

7. Type of Ground Truth Used

• Animal Model (Remodeling): The ground truth for remodeling capability would be established through histological analysis, radiographic imaging, and potentially biomechanical testing of the bone regeneration in the animal model, comparing the CANCELLO-PURE™ Wedge to an allograft.
• Viral Inactivation Study: The ground truth for viral inactivation would be established by laboratory assays capable of detecting and quantifying viruses. "Below detectable limits" serves as the ground truth.

8. Sample Size for Training Set

• Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The studies described are for non-AI medical device validation.

9. How Ground Truth for Training Set was Established

• Not Applicable. As there is no training set mentioned, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The logo consists of a black square on the left, followed by the word "Regeneration" in a bold, sans-serif font. Below the word "Regeneration" is the phrase "TECHNOLOGIES, INC." in a smaller, sans-serif font. The letters are all capitalized.

11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA

K072327

Tel [phone] Toll Free 877.343.6832 Fax [phone] www.rtix.com

Attachment 4: 510(K) Summary

August 17, 2007

Submitted by: Lisa Simpson Regeneration Technologies, Inc. 11621 Research Circle Alachua, FL 32615 Phone: [phone] x4326 Fax: [phone] Proprietary Name: CANCELLO-PURE™ Wedge

Common Name: Filler, bone void, calcium compound

Product Code: MQV, Orthopedics Panel

Code Section: 21 CFR 888.3045

Substantial Equivalence:

The CANCELLO-PURE™ Wedge is substantially equivalent to predicate devices in materials, design, and function.

Description:

The CANCELLO-PURE™ Wedge is machined into a wedge shape from bovine bone processed with the BioCleanse® Tissue Sterilization Process. These products are preshaped for surgeon convenience.

Intended Use:

These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodels into the recipient's skeletal system.

Summary of Technological Characteristics:

The CANCELLO-PURE™ Wedge has materials, design and function equivalent to predicate devices. The source of bovine bone used in the manufacture of these products is a closed herd located in the U.S.A.

The BioCleanse® Tissue Sterilization Process, used in the manufacture of these products, has been shown to render processed bovine bone capable of remodeling comparably to

OCT 2 4 2007

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Image /page/1/Picture/0 description: The image shows the logo for Regeneration Technologies, Inc. The word "Regeneration" is in large, bold, black letters with a trademark symbol in the upper right corner. Below that, in smaller letters, is the text "TECHNOLOGIES, INC."

11621 Research Circle Post Office Box 2650 Alachua, FL 32616-2650 USA

Tel [phone] Toll Free 877.343.6832 Fax [phone] www.rtix.com

allograft in an animal model. A viral inactivation study using a worst-case representation of the BioCleanse® process has shown reduction of a panel of viruses to below detectable limits.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Regeneration Technologies, Inc. % Ms. Lisa Simpson 11621 Research Circle P. O. Box 2650 Alachua, FL 32616-2650

OCT 2 4 2007

Re: K072327

Trade/Device Name: Cancello-Pure™ Wedge Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: September 20, 2007 Received: September 24, 2007

Dear Ms. Simpson:

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. 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. Lisa Simpson

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Millman

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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Attachment 2: Indications for Use

510(k) Number (if known):

Device Name:

CANCELLO-PURE™ Wedge

Indications for Use:

These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a void filler that remodel into the recipient's skeletal system.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PACE OF NEEDED)

Mark A. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 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.