(308 days)
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Not Found
No
The summary does not mention AI, ML, image processing, or any performance metrics typically associated with AI/ML algorithms. The device description and intended use are purely mechanical/structural.
No.
The HAIS is an implant system intended for single tooth replacement and to support dental prostheses, which are restorative rather than therapeutic functions.
No
The device is described as an implant system for tooth replacement and supporting prostheses, not for diagnosing medical conditions.
No
The device description clearly identifies the device as a "hexagonal Abutment Implant System," which is a physical implant and not software.
Based on the provided information, the Kwan HAIS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as an implant system for tooth replacement and supporting dental prostheses. This is a surgical and restorative application within the body.
- Device Description: The description refers to an "Abutment Implant System," which is a physical device implanted into bone.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on in vitro analysis.
- Using reagents or calibrators.
IVD devices are used to perform tests on samples taken from the human body to provide information about the body. The Kwan HAIS is a device that is placed into the body to perform a structural function.
N/A
Intended Use / Indications for Use
The Kwan HAIS is intended for single tooth replacement, as an intermediate abutment on long span bridgework, as distal abutments on free end edentulous areas to be restored with fixed bridgework, to support over dentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla. The HAIS is intended to be used in single stage and two stage procedures.
Product codes
DZE
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1997
Biomedical Implant Technology, Incorporated C/O Mr. Ronald McCarley 10304 Islander Drive Boca Raton, Florida 33498
Re : K962753 Kwan Hexagonal Abutment Implant System Trade Name: (HAIS) Regulatory Class: III Product Code: DZE Dated: October 11, 1996 Received: October 17, 1996
Dear Mr. McCarley:
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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੇ substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (CME) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, the Food and Drug Administration (FDA) action. 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.
1
Page 2 - Mr. McCarley
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. ------Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-320) at (301) 594-4639. Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Heald W. Shipp
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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REVISED INDICATIONS FOR USE STATEMENT (revised 1/10/96)
Page 1 of 1
510(k) Number: K962753
Device Name: Kwan hexagonal Abutment Implant System (HAIS)
Indications for Use:
The Kwan HAIS is intended for single tooth replacement, as an intermediate abutment on long span bridgework, as distal abutments on free end edentulous areas to be restored with fixed bridgework, to support over dentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla. The HAIS is intended to be used in single stage and two stage procedures.
Per 21 CFR 801.109
Note: Underlined portion represents amendment.
) Number
Heedl Stupp (for MSR)
-sion Sign-Off)
ion of Dental, Infection Control, General Hospital Devices
Prescription Use
(Per 21 CFR 801.109)
P.O2