(77 days)
Not Found
No
The summary describes a bone graft material and its intended use, with no mention of AI or ML technology in the device description, intended use, or specific sections for AI/ML mentions.
Yes
The device is described as "Bone Graft Material" intended for "filling bony voids or gaps of the skeletal system," which is a therapeutic intervention aimed at promoting healing and restoring function in the bone.
No
The device is described as a bone graft material used for filling bony voids, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states "HEALOS Bone Graft Material" and describes it as a "bone void filler," indicating a physical material, not software. The submission is for adding dimensional and volumetric configurations to this material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that HEALOS Bone Graft Material is for filling bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description focuses on the physical properties and configurations of the bone graft material.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.
- Anatomical Site: The device is applied directly to the skeletal system, which is consistent with a therapeutic bone graft.
IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
HEALOS Bone Graft Material ("HEALOS"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, 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. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
Product codes
MQV
Device Description
Addition of dimensional and volumetric configurations to the HEALOS Bone Graft Material
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, spine, and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards have been established for this type of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Ko43308
FEB 1 6 2005
IX. 510(k) Summary
DePuy Spine, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780
Sharon Starowicz CONTACT PERSON:
November 5, 2004 DATE PREPARED:
CLASSIFICATION NAME: Filler, calcium sulfate preformed pellets
PROPRIETARY NAME: HEALOS Bone Graft Material
PREDICATE DEVICES: HEALOS Bone Graft Material (K012751)
Addition of dimensional and volumetric configurations DEVICE DESCRIPTION: to the HEALOS Bone Graft Material
HEALOS Bone Graft Material ("HEALOS"), combined INTENDED USE: with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, 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. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
The principal components of HEALOS are Type I MATERIALS: bovine collagen and hydroxyapatite.
PERFORMANCE No performance standards have been established for DATA: this type of device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
FEB 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Starowicz Director of Regulatory Affairs DePuv Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K043308
Trade/Device Name: HEALOS® Bone Graft Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: January 21, 2005 Received: January 24, 2005
Dear Ms. Starowicz:
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 r ou may) after or visions 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 may oe subject to back acceral 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 or any I 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Starowicz
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin mailing of substantial equivalence of your device to a legally premaired notification: The PPA mailing of 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 If you desire specific advice ion Jour (240) 276-0120. Also, please note the regulation entitled, Comact the Office of Compullion as (21 notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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 yours,
Mark A. Milliken
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
lll. Indications for Use
510(k) Number (if known):
HEALOS® Bone Graft Material Device Name:
Indications For Use:
HEALOS Bone Graft Material ("HEALOS"), combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, 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. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
Prescription Use (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)
Page 1 of _
Mark A. Milam
General, Restorative. and Neurological Devices
510(k) Number K043308