(62 days)
No
The device description focuses on the materials, dimensions, and surgical tools for a dental implant system. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies are bench tests comparing the new system to predicate devices, not evaluating algorithmic performance.
Yes
The device is described as an implant system designed for long-term fixation of denture installations, which directly contributes to the treatment or amelioration of a medical condition (edentulism), fitting the definition of a therapeutic device.
No
The device is an implant system designed for long-term fixation of dentures, not for diagnosing medical conditions.
No
The device description explicitly states it is a set of machined titanium screws, abutments, denture caps, and surgical tools, which are all physical hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide intra-bony long term fixation of denture installations in partially or fully edentulous patients." This describes a surgical implant for structural support, not a test performed on biological samples to diagnose or monitor a condition.
- Device Description: The description details a system of titanium screws, abutments, and instruments for surgical implantation. This aligns with a medical device used in a surgical procedure, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (biomarkers, pathogens, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly a surgical implant system.
N/A
Intended Use / Indications for Use
The ACE Surgical Secure™ Locator® 3.25mm Implant System is is designed to provide Intra-bony long term fixation of denture installations in partially or fully edentulous patients.
Product codes
DZE, NHA
Device Description
The ACE Secure™ Locator® 3.25mm Implant System is a set of machined commercially pure (CP) titanium (Grade 4) screws, intended to provide Intra-bony long term fixation of denture installations in partially or fully edentulous patients. The implants are supplied sterlie in 3.25 mm diameter, and in lengths of 8, 10, 11.5, 13, and 15 mm, and with Zest Locator® implant Anchor Abutments and Denture Cap Males (Identical to those cleared under K092594)/n standard tray packaging and include placement instruments.
The screw raw material is Ti (CP-Grade 4) per ASTM F67 standard. The screw Implants, abutments and denture caps are identical In materials and characteristics to that cleared under K092594 and K954513. These screws are supplied sterile in standard Tyveke tray packaging along with applicable instructions for use.
The ACE Secure™ Locatore 3,25mm Implant System Is a comprehensive system using same and similar surgical tools (a Two Step Lag Bur CA is replaced by a Kirschner Pliot Bur, and the optional Parallel Pin/Depth Gauge and 2.8 mm twist drill are now supplied standard) made from high strength corrosive resistant stainless steel (17-4, H-900) and a similar (the predicate tray had holes and markings to accommodate the predicate screw implant sizes, the candidate device will have two trays - one solely for candidate screw implant sizes, and another for the combined predicate and candidate screw implant sizes) polycarbonate sterlization tray accessory as in the predicate ACE Surgical Secure-Mini™ Locator® Implant svstem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-bony
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)
bench testing demonstrated there was no difference in the fundamental technology, performance, safety, or effectiveness between the ACE Surgical Secure™ 3.25mm Implant System and the specified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACE Surgical Secure-Mini™ Locator® Implant System, K092596, ACE Screw Dental Implant System, K954513
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
Mr. Michael Nilo January 11, 2010 Page 3
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter Name: | ACE Surgical Supply Co., Inc. | |
|---|---|---|
| Submitter Address : | 1034 Pearl St., Brockton, MA 02301 | JAN 1 4 2010 |
| Contact Person: | J. Edward Carchidi, DDS | |
| Phone Number: | (508) 588-3100 | |
| Fax Number: | (508) 523-3140 | |
| Date Prepared: | November, 2009 | |
| Device Trade Name: | ACE Surgical Secure™ Locator® 3.25mm Implant System | |
| Device Common Name: | Endosseous Implant Screw | |
| Classification Name: | Implant, Endosseous, Root form, product code DZE, | |
| Endosseous Dental Implant Abutment, product code NHA | ||
| Predicate device: | ACE Surgical Secure-Mini™ Locator® Implant System, K092596 | |
| ACE Screw Dental Implant System, K954513 | ||
| Reason for submission: | Not previously marketed in the USA |
Device Description and Materials:
The ACE Secure™ Locator® 3.25mm Implant System is a set of machined commercially pure (CP) titanium (Grade 4) screws, intended to provide Intra-bony long term fixation of denture installations in partially or fully edentulous patients. The implants are supplied sterlie in 3.25 mm diameter, and in lengths of 8, 10, 11.5, 13, and 15 mm, and with Zest Locator® implant Anchor Abutments and Denture Cap Males (Identical to those cleared under K092594)/n standard tray packaging and include placement instruments.
The screw raw material is Ti (CP-Grade 4) per ASTM F67 standard. The screw Implants, abutments and denture caps are identical In materials and characteristics to that cleared under K092594 and K954513. These screws are supplied sterile in standard Tyveke tray packaging along with applicable instructions for use.
The ACE Secure™ Locatore 3,25mm Implant System Is a comprehensive system using same and similar surgical tools (a Two Step Lag Bur CA is replaced by a Kirschner Pliot Bur, and the optional Parallel Pin/Depth Gauge and 2.8 mm twist drill are now supplied standard) made from high strength corrosive resistant stainless steel (17-4, H-900) and a similar (the predicate tray had holes and markings to accommodate the predicate screw implant sizes, the candidate device will have two trays - one solely for candidate screw implant sizes, and another for the combined predicate and candidate screw implant sizes) polycarbonate sterlization tray accessory as in the predicate ACE Surgical Secure-Mini™ Locator® Implant svstem.
Intended Use:
ACE Surgical Secure™ Locator® 3.25mm Implant System is is designed to provide Intra-bony long term fixation of denture installations in partially or fully edentulous patients.
Substantial Equivalence/ Device - Technological Characteristics and Comparison to Predicate Device(s):
The ACE Surgical Secure™ Locator® 3.25mm Implant System is substantially equivalent to the ACE Surgical Secure-Mini™ Locator® Implant System, K092594 and the ACE Screw Dental Implant System . K954513.
Among the information and data presented in the 510(K) submission to support the substantial equivalency of the ACE Surgical Secure™ Locator® 3.25mm Implant System to the specified predicate devices are: 1) device description, 2) Indications for use and Intended use(s), 3) bench test results, 4) materials, and 5) labeling. In particular, the bench testing demonstrated there was no difference in the fundamental technology, performance, safety, or effectiveness between the ACE Surgical Secure™ 3.25mm Implant System and the specified predicate devices.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
J. Edward Carchidi, D.D.S. President ACE Surgical Supply Company, Incorporated 1034 Pearl Street Brockton, Massachusetts 02301
JAN 1 4 2010
Re: K093518
Trade/Device Name: ACE Surgical Secure™ Locator® 3.25mm Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 14, 2009 Received: December 16, 2009
Dear Dr. Carchidi:
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 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.
2
Page 2 - Dr. Carchidi
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); medical device reporting (reporting of medical.device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
ph for
Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number: K093518
Device Name: ACE Surgical Secure™ Locator® 3.26mm Implant System
Indications For Use:
The ACE Surgical Secure™ Lecation 3.25mm Implant System is is designed to provide intra-bony long term fixation of denture installations in partially or fully edentulous patients.
Prescription Use. X (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)
Abbotz DDS for Dr. K.P. Mulaly (Acting)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number. K093518
A-2