(403 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a synthetic bone substitute, with no mention of AI or ML.
Yes
The device is described as "intended to aid in the healing of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall," which aligns with the definition of a therapeutic device as it is designed to treat or alleviate a medical condition.
No
The device is a bone substitute material intended to aid in healing, not to diagnose a condition.
No
The device description clearly states it is a "synthetic, calcium phosphate hydroxylapatitic material" provided in "dry white powder form," which is a physical substance, 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 the material is intended to "aid in the healing of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall." This describes a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details a "synthetic, calcium phosphate hydroxylapatitic material" that is mixed and applied to defects. This is a physical material used for structural support and healing, not a reagent or instrument used to analyze biological samples for diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
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
a-BSM™ Bone Substitute Material is a synthetic calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.
Product codes
LYC
Device Description
a-BSM™ Bone Substitute Material Kit is a synthetic, calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, to reduce alveolar bone pocket depth and increase alveolar bone thickness and height, to aid in gain in clinical attachment and for repair of cysts or other defects in the alveolar ridge or wall. &-BSM™ Bone Substitute Material Kit is provided in dry white powder form, it contains no pvrophosphates or amorphous tricalcium phosphate. The device is mixed with sterile water or saline just prior to its application to the desired periodontal defect.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal bone wall, alveolar ridge or wall
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)
Testing of x-BSM™ Bone Substitute Material was designed to characterize the finished material and assure the biocompatibility of the device. Biocompatibility testing included Skin Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, and Rabbit IM. Additionally, elemental analysis, x-ray diffraction (XRD), Fourier Transform Infrared (FTIR) Spectroscopy and sterility testing (USP 23) demonstrated that the device conforms to ASTM Standard F 1185 for Composition of Ceramic Hydroxylapatite for Surgical Use and that the material is sterile.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OsteoGen® (manufactured by Impladent, Ltd.), HAPSET® (manufactured by Lifecore Biomedical)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
AUG - 5 1997
510(K) SUMMAR for ETEX x-BSM™ Bone Substitute Material Kit
DATE PREPARED I .
June 21, 1996
2. SPONSOR INFORMATION
Address ETEX Corporation 38 Sidney Street. Suite 370 Cambridge, MA 02139
Telephone: (617)577-7270
Contact: DoSuk D. Lee, Ph.D.
3. DEVICE NAME
Proprietary Name: α-BSM™ Bone Substitute Material Kit Common/Usual_Name: Bone Graft Material Classification Name: Endosseous Implant for Bone Filling and /or Augmentation
4. DEVICE DESCRIPTION AND INTENDED USE
«-BSM™ Bone Substitute Material Kit is a synthetic, calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, to reduce alveolar bone pocket depth and increase alveolar bone thickness and height, to aid in gain in clinical attachment and for repair of cysts or other defects in the alveolar ridge or wall. &-BSM™ Bone Substitute Material Kit is provided in dry white powder form, it contains no pvrophosphates or amorphous tricalcium phosphate. The device is mixed with sterile water or saline just prior to its application to the desired periodontal defect.
న్. PREDICATE DEVICES
x-BSM™ Bone Substitute Material Kit is substantially equivalent to devices currently in U.S. commercial distribution which are classified as endosseous implant for bone filling and/or augmentation. Examples of other such products include OsteoGen® (manufactured by Impladent, Ltd.) and HAPSET® (manufactured by Lifecore Biomedical). All three products are forms of apatitic calcium phosphate with similar performance in the body.
1
6. DEVICE TESTING
Testing of x-BSM™ Bone Substitute Material was designed to characterize the finished material and assure the biocompatibility of the device. Biocompatibility testing included Skin Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity, and Rabbit IM. Additionally, elemental analysis, x-ray diffraction (XRD), Fourier Transform Infrared (FTIR) Spectroscopy and sterility testing (USP 23) demonstrated that the device conforms to ASTM Standard F 1185 for Composition of Ceramic Hydroxylapatite for Surgical Use and that the material is sterile.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1997
DoSuk D. Lee, Ph.D. Etex Corporation 38 Sidney Street, Suite 370 Cambridge, Massachusetts 02139
Re: K962548 BSM Bone Substitute Material Kit Trade Name: Requlatory Class: Unclassified Product Code: LYC Dated: December 17, 1996 Received: December 23, 1996
Dear Dr. Lee:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. substantially equivalent determination assumes compliance with the Cood Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Dr. Lee
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small/Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
A. Timothy Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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PREMARKET NOTIFICATION
DEVICE NAME AND INTENDED USE STATEMENT
Device Name: α-BSM™ Bone Substitute Material Kit
510(k) Number: K962548
Indications/ Intended Uses:
a-BSM™ Bone Substitute Material is a synthetic calcium phosphate hydroxylapatitic material intended to aid in the healing of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.
PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NECESSARY
| Susan Runner | ||
|---|---|---|
| Chief Division Sign-Off: CDRH, Office of Device Evaluation (ODE) | ||
| Division of Dental, Infection Control, | ||
| and General Hospital Devices | ||
| 510(k) Number: | K192548 | |
| Prescription Use | ||
| ✓ | or | Over-the-Counter Use |