(89 days)
AlloCraft is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. AlloCraft can be used to fill bone voids in the posterolateral spine. It is in licated for use in the treatment of surgically created osseous defects or oss :ous defects created from traumatic injury.
AlloCraft is intended for single patient use only.
AlloCraft, like all bone graft materials c >ntaining demineralized bone matrix, is a bone vold finer mallinary of paring structures. AlloCraft is packaged in two Separate Syringes, one contaming tresus pended in sterile saline. When mixed, the containing acchuiar dermal maxxture that can be molded or handled by the surgeon, or placed directly into the osse >us defect site.
The provided text is a 510(k) summary for the AlloCraft™ DBM device, seeking clearance as a medical device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in a human clinical setting with defined metrics like sensitivity, specificity, or accuracy.
The performance data mentioned in the document is limited to preclinical assessments:
Performance Data Section Analysis:
- Study Description: "LifeCell has assessed the osteoconductive and osteoinductive properties of AlloCraft in valid animal models. The Company also establishes the AlloCraft in valid anniala nivach lot of the DBM component of AlloCraft in ostcomadel. In all instances, /11loCraft functioned as intended and the bone formation observed was as expected."
- Acceptance Criteria & Device Performance: This section does not define specific, quantifiable acceptance criteria (e.g., "X% bone formation at Y weeks"). Instead, it broadly states that the device "functioned as intended" and "bone formation observed was as expected." This is a qualitative statement rather than a measurable metric.
- Sample Size (Test Set) and Data Provenance: The document states "valid animal models" and "each lot of the DBM component" but does not specify the number of animals or lots used in these studies. The data provenance is animal models, not human data.
- Experts and Ground Truth: The document does not mention the use of experts to establish a ground truth. Bone formation would likely be assessed histologically or radiographically in animal models, but the specific method, number of observers, or their qualifications are not provided.
- Adjudication Method: Not applicable, as there's no mention of expert review or consensus.
- MRMC Comparative Effectiveness Study: No MRMC study was conducted or mentioned. The performance data is solely on the device's material properties in animal models, not its comparative effectiveness with human readers.
- Standalone Performance: The described "performance data" is focused on the material properties and biological response of the device in animal models. It does not measure a "standalone" algorithmic performance as typically understood for AI/software devices.
- Type of Ground Truth: The ground truth used was observed bone formation in animal models, likely through methods like histological analysis.
- Training Set Sample Size: Not applicable, as this is not an AI/ML device that requires a training set.
- Training Set Ground Truth Establishment: Not applicable.
Summary Table (Based on available information from the document):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoconductive properties in valid animal models | Functioned as intended; bone formation observed as expected |
| Osteoinductive properties in valid animal models | Functioned as intended; bone formation observed as expected |
| Each lot of DBM component in osteomodel (a type of animal model) | Functioned as intended; bone formation observed as expected |
Additional Information Not Present in the Document:
- No specific quantifiable acceptance criteria (e.g., minimum percentage of bone formation, specific strength values).
- No human clinical study data.
- No detail on the methodology for assessing "bone formation as expected" (e.g., specific assays, histological grading scales).
- No information regarding blinding or independent review of animal study results.
- No information on the statistical significance or confidence intervals of the findings.
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DEC 2 8 2005
510(K) SUMMARY
LifeCell Corporation's AlloCraft™ DBM
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
LifeCell Corporation One Millennium Way Branchburg, NJ 08869
(908) 947-1115 Phone: Facsimile: (908) 947-1095
Lorraine T. Montemurro Contact Person:
Date Prepared:December 14, 2005,
Name of Device and Name/Address of Sponsor
AlloCraft™ DBM
LifeCell Corporation One Millennium Way Branchburg, NJ 08869
Common or Usual Name
Bone graft material
Classification
Class II
Regulation Number
21 CFR §888.3045
Product Codes
MBP and MQV
Classification Name
Resorbable calcium salt bone void filler
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Musculoskeletal Transplant Foundation' ; DBX® Demineralized Bone Matrix Wright Medical's AlloMatrix® Exactech's Resorbable Bone Paste
Intended Use / Indications for Use
AlloCraft is intended for use as bone void filler for voids or gaps that are not AlloCraft is intended for use as bone vera most can be used to fill bone
intrinsic to the stability of the bony structure. AlloCraft can be used of mitrinsic to the stability of the occiry an in licated for use in the treatment of volds in the posterolateral spiner some defects created from traumatic injury.
AlloCraft is intended for single patient use only.
Technological Characteristics
AlloCraft, like all bone graft materials c >ntaining demineralized bone matrix, is a Affocraft, fire an bone grail mated or p aced within osseous defects that are not bone vold finer mallinary of paring structures. AlloCraft is packaged in two Intrinsit to the stability of the bony e de nineralized bone matrix and a second Separate Syringes, one contaming tresus pended in sterile saline. When mixed, the containing acchuiar dermal maxxture that can be molded or handled by the surgeon, or placed directly into the osse >us defect site.
Performance Data
LifeCell has assessed the osteoconductive and osteoinductive properties of AlloCraft in valid animal models. The Company also establishes the AlloCraft in valid anniala nivach lot of the DBM component of AlloCraft in ostcomadel. In all instances, /11loCraft functioned as intended and the bone formation observed was as expected.
Substantial Equivalence
AlloCraft is as safe and effective as the DBX and Allomatrix bone graft materials. AlloCraft is as sare and offeon ( uses ar d similar indications, technological AnoCraft has the same miches of operation as its predicate devices. The minor technological differences between Allot Traft and its predicate devices raise no technological afferences ectiveness. Performance data demonstrates that new issues of safety of offective as the predicate devices. Thus, AlloCraft is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A."
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2005
Ms. Lorraine T. Montemurro Manager, Regulatory Affairs LifeCell One Millennium Way Branchburg, New Jersey 08876
Re: K052735 S1
Trade/Device Name: AlloCraft™DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MBP, MQV Dated: December 14, 2005 Received: December 16, 2005
Dear Ms. Montemurro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to 1125 20, 2017 11:25 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 I ou mayy are or ovisions 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 - Lorraine T. Montemurro
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 Pouchot
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AlloCraft™ DBM
Indications for Use:
AlloCraft is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. AlloCraft can be used to fill bone voids in the posterolateral spine. It is in licated for use in the treatment of surgically created osseous defects or oss :ous defects created from traumatic injury.
AlloCraft is intended for single patient use only
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Barbara Brechund for Ryan
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052735
§ 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.