(90 days)
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No
The document describes a bone graft material composed of collagen and hydroxyapatite, with no mention of AI or ML technology in its description, intended use, or performance studies.
Yes.
The device is described as "Bone Graft Material" intended for "filling bony voids of the skeletal system" and is "resorbed and remodeled into new bone as part of the natural healing process," directly supporting healing and restoration of bodily function.
No
Explanation: The device is a bone graft material intended for use in filling bony voids. Its purpose is to physically fill defects and provide a scaffold for new bone formation, not to diagnose a condition.
No
The device description clearly states that HEALOS is a "mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation," 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 clearly states that HEALOS is a bone graft material intended for filling bony voids in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition and physical form of the material, which is designed for surgical implantation and integration with bone tissue. This is consistent with a medical device used for treatment or repair, not for testing samples outside the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on material characteristics, in vivo performance (bone healing in animal models), and clinical testing related to its function as a bone graft. These are not studies typically associated with validating the performance of an IVD.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. HEALOS is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
HEALOS®, combined with autogenous bone marrow, is intended for use in filling bony voids on gaps 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 healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV, LYC
Device Description
HEALOS® Bone Graft Material (HEALOS) is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of HEALOS are Type I bovine collagen and hydroxyapatite. HEALOS is approximately 30% mineral by weight. The collagen is processed prior to mineralization using aqueous and organic purification steps to reduce lipids, salts, and endotoxins. Hydroxyapatite coats the surface of the collagen fibers by the controlled addition of calcium chloride, sodium phosphate, and sodium hydroxide. The mineralized collagen fibers are fixed into a three dimensional, open-cell matrix.
HEALOS is provided as a sterile, dry material that must be hydrated with autogenous bone marrow at the point of use. HEALOS can be cut into shapes optimized for a specific population and is designed to retain its shape and physical integrity following specific population and is designed to simily resorbed during the natural process of bone formation and remodeling.
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., the extremities, spine and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
HEALOS has undergone material characterization testing (calcium and sodium content; mineral III.ALOS mas under gone material texide content; mechanical stability of hydroxyapatite coating; X-ray diffraction; and mercury porosimetry); performance testing (pH measurement; in יוֹנִי מַ solubility; and in vivo testing (rabbit radial defect model, spinal fusion in any and fision solubinty, and in VIVO testing (intracutaneous toxicity; systemic toxicity; genotoxicity; cytotoxicity; sensitization; and bone implantation); and clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K994337, K980817, K990131, K0000515, K974399, K003339, K000122
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.
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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).
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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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NOV 1 4 2001
510(k) SUMMARY
| Name of 510(k) sponsor: | Orquest, Inc. |
|---|---|
| Address: | 365 Ravendale Drive |
| Mountain View, CA 94043 | |
| Telephone: 650 237.4800 | |
| Fax: 650 903.1903 | |
| Contact information: | Kristine F. Lahman |
| Telephone: 650-237-4852 | |
| Fax: 650-903-0157 | |
| Date summary prepared: | August 15, 2001 |
| Proprietary name of device: | HEALOS® Bone Graft Material |
| Generic/classification name: | Bone void filler |
| Product code (classification): | MQV (not classified) |
Legally Marketed Predicate Devices:
Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337); Pro Osteon Implant 500R Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399); and Collagen Periodontal Membrane (K003339) Collagraft Strip Bone Graft Matrix (K000122)
Device Description:
HEALOS® Bone Graft Material (HEALOS) is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of HEALOS are Type I bovine collagen and hydroxyapatite. HEALOS is approximately 30% mineral by weight. The collagen is processed prior to mineralization using aqueous and organic purification steps to reduce lipids, salts, and endotoxins. Hydroxyapatite coats the surface of the collagen fibers by the controlled addition of calcium chloride, sodium phosphate, and sodium hydroxide. The mineralized collagen fibers are fixed into a three dimensional, open-cell matrix.
1
HEALOS is provided as a sterile, dry material that must be hydrated with autogenous bone marrow at the point of use. HEALOS can be cut into shapes optimized for a specific population and is designed to retain its shape and physical integrity following specific population and is designed to simily resorbed during the natural process of bone formation and remodeling.
Intended Use
HEALOS, combined with autogenous bone marrow, is intended for use in filling bony voids on gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically gaps mat are not maniste to the backey or usulting from traumatic injury to the bone. HEALOS
created osseous defects or osseous defects resulting from traumatic injury to the should not be used to treat large defects that in the surgeon's opinion would fail to heal should not oc used to treat targe delects that in that is resorbed and remodeled into new bone as part of the natural healing process.
Technological Characteristics
The intended use, product design, composition, physical stucture, and target population of a The miended use, product design, occipotiates pay leared and legally marketed predicate devices named in the chart below as follows.
- HEALOS and the predicate devices, Vitoss (K994337) and Pro Osteon (K980817, . K990131, and K000515) are intended for the same use and target populations.
- HEALOS and the predicate devices are sterile and are all matrices that provide an � environment for new bone ingrowth.
- Like Collagraft (K000122) and Bio-Oss Collagen (K974399), HEALOS is a . combination of collagen and bone mineral. Although Bio-Oss has a smaller confortion of collagen than HEALOS (10% vs. 70%), there are other dental bone filling augmentation materials that are comprised entirely of collagen (i.e., the named predicate device, Collagen Periodontal Membrane, K00339).
- HEALOS and the predicate devices are resorbed following implantation. The . extent and rate of absorption differ between HEALOS and the predicate devices and across predicate devices. These differences in resorption rate do not present safety or efficacy issues because HEALOS is intended to fill bony gaps and defects and not to impart mechanical strength to osseous defects.
- Although HEALOS differs from Vitoss, Pro Osteon, and Bio-Oss with regard to . form (strips vs. granules), it is similar in form to the Collagen Periodontal Membrane.
Testing
HEALOS has undergone material characterization testing (calcium and sodium content; mineral III.ALOS mas under gone material texide content; mechanical stability of hydroxyapatite coating;
KO12751
Q OF 3
2
K012751
30F3
X-ray diffraction; and mercury porosimetry); performance testing (pH measurement; in יוֹנִי מַ solubility; and in vivo testing (rabbit radial defect model, spinal fusion in any and fision solubinty, and in VIVO testing (intracutaneous toxicity; systemic toxicity; genotoxicity; cytotoxicity; sensitization; and bone implantation); and clinical testing.
Conclusions
The results from these tests support the substantial equivalence of HEALOS Bone Graft Material to the predicate devices.
3
Image /page/3/Picture/12 description: The image shows a logo for the National Institute of Health. The logo consists of a stylized depiction of a human figure with three curved lines representing the body and head. To the left of the figure, the text "NATIONAL INSTITUTE OF HEALTH" is arranged in a semi-circular fashion, following the curve of the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2001
Ms. Kristine F Lahman Orquest, Inc. 365 Ravendale Drive Mountain View, California 94043
Re: K012751
Trade/Device Name: HEALOS® Bone Graft Material Regulatory Class: Unclassified Product Code: MOV and LYC Dated: August 15, 2001 Received: August 16, 2001
Dear Ms. Lahman:
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.
4
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Mark M Mckesson
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
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INDICATIONS FOR USE STATEMENT
| NOV | 1 4 2001 |
|---|---|
| ----- | ---------- |
| Applicant: | Orquest, Inc. |
|---|---|
| 510(k) Number: | K012751 |
| Device Name: | HEALOS® Bone Graft Material |
| Indications for Use: | HEALOS® Bone Graft Material (“HEALOS”), combined with autogenous bone marrow, is intended for use in filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis) that ar pony shunature These defects may be |
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 healing process.
or gaps
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Participation Use ✓
Prescription
Over-the Counter Use
for Mark n Milkerson
(Division Sign-Off)
Div. (Dental) Restorative
and Surgical Devices
510(k) Number K012757