(49 days)
No
The summary describes a bone graft substitute and a system for mixing and delivering it. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on equivalence to predicate devices based on material properties and delivery system design, not algorithmic performance.
Yes
The device is a bone graft substitute intended to fill bony voids or gaps and is resorbed and remodeled into new bone as part of the natural healing process, which directly addresses a medical condition or ailment.
No
The device is a bone graft substitute and a mixing/delivery system, intended for filling bony voids, not for diagnosing conditions.
No
The device description clearly states that HEALOS® FX is a bone graft substitute made of physical components (Type I bovine collagen and hydroxyapatite) and the HEALOS® FX Graft Mixing and Delivery System is a physical system for mixing and delivering the graft. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the skeletal system during surgery. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is a bone graft substitute and a system for mixing and delivering it. These are materials and tools used in surgical procedures, not for testing samples outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
HEALOS® FX Bone Graft Substitute:
- HEALOS® FX Bone Graft Substitute ("HEALOS FX"), 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®FX is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
HEALOS® FX Graft Mixing and Delivery System Indications for Use: The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.
Product codes (comma separated list FDA assigned to the subject device)
MQV, FMF
Device Description
HEALOS® FX Bone Graft Substitute: HEALOS® FX Bone Graft Substitute ("HEALOS® FX"), 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. The principal components of the HEALOS FX Bone Graft Substitute are Type I bovine collagen and hydroxyapatite that are resorbed and remodeled into new bone as part of the natural healing that are
HEALOS® FX Graft Mixing and Delivery System: The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.
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)
HEALOS® FX Bone Graft Substitute: A performance evaluation has been included to support the safety and effectiveness of HEALOS®FX compared to the predicate devices.
HEALOS® FX Graft Mixing and Delivery System: No performance standards have been established for this type of device. The substantial equivalence of the HEALOS® FX Graft Mixing and Delivery System to the predicate devices (Symphony Graft Delivery System (K003286), Harvest Graft Delivery System (K043261), and Imbibe II Syringe (K030208) is based upon equivalence in design, principles of operation, indications and intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K012751, K043308, K032288, K003286, K043261, K030208
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K062495 Pg1/2
XI. 510(k) Summary
| SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02780
Tel: 508-828-3537
Fax: 508-828-3711 | OCT 13 2006 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Melanie Archer | |
| DATE PREPARED: | August 23, 2006 | |
| CLASSIFICATION NAME: | Resorbable calcium salt bone void filler
Piston Syringe | |
| PROPRIETARY NAME: | HEALOS® FX Bone Graft Substitute
HEALOS® FX Graft Mixing and Delivery System | |
| PREDICATE DEVICES: | HEALOS® Bone Graft Substitute (K012751 and K043308)
Vitoss® Scaffold Foam Bone Graft Material (K032288)
Symphony® Graft Delivery System (K003286)
Harvest® Graft Delivery System (K043261)
Imbibe® II Syringe (K030208) | |
DEVICE DESCRIPTION:
HEALOS® FX Bone Graft Substitute:
HEALOS® FX Bone Graft Substitute ("HEALOS® FX"), 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. The principal components of the HEALOS FX Bone Graft Substitute are Type I bovine collagen and hydroxyapatite that are resorbed and remodeled into new bone as part of the natural healing that are
HEALOS® FX Graft Mixing and Delivery System:
The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.
1
Ko6245 1/2
INTENDED USE:
HEALOS® FX Bone Graft Substitute:
- HEALOS® FX Bone Graft Substitute ("HEALOS FX"), 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®FX is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
HEALOS® FX Graft Mixing and Delivery System Indications for Use: The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.
MATERIALS:
HEALOS® FX Bone Graft Substitute: Calcium salt with Type I bovine collagen.
HEALOS® FX Graft Mixing and Delivery System: Makrolon Rx2530-1118, Cycolac ABS MG47MD, EPDM, Loctite cyanoacrylate, polyethylene, acrylic copolymer.
PERFORMANCE
DATA:
HEALOS® FX Bone Graft Substitute:
A performance evaluation has been included to support the safety and effectiveness of HEALOS®FX compared to the predicate devices.
HEALOS® FX Graft Mixing and Delivery System:
No performance standards have been established for this type of device. The substantial equivalence of the HEALOS® FX Graft Mixing and Delivery System to the predicate devices (Symphony Graft Delivery System (K003286), Harvest Graft Delivery System (K043261), and Imbibe II Syringe (K030208) is based upon equivalence in design, principles of operation, indications and intended use.
2
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 with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2006
DePuy Spine, Inc % Ms. Melanie Archer Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K062495
Trade/Device Name: HEALOS® FX Bone Graft Substitute, HEALOS® Graft Mixing and Deliver Systems Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, FMF Dated: August 23, 2006 Received: August 25, 2006
Dear Ms. Archer:
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, and 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.
3
Page 2 – Ms. Melanie Archer
This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotter will and hyb your e 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
For
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use IV.
KO62495 510(k) Number (if known):
HEALOS® FX Bone Graft Substitute Device Name: HEALOS® FX Graft Mixing and Delivery System
HEALOS® FX Bone Graft Substitute Indications For Use:
HEALOS® FX Bone Graft Substitute ("HEALOS FX"), 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® FX is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
HEALOS® FX Graft Mixing and Delivery System Indications for Use:
The HEALOS® FX Graft Mixing and Delivery System is indicated for the mixing and delivery of HEALOS® FX to a surgical site.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
14062493 510(k) Number
DePuy Spine, Inc.