(90 days)
The Steri-Mate Handpiece Sleeve with LED Light is indicated for:
-
Provides illumination to enhance visibility in the clinical working area during ultrasonic scaling procedures with the Steri-Mate handpiece.
-
When the lighted sleeve is installed on the Steri-Mate handpiece, the soft tapered grip provides multiple pinch points, to enhance ergonomics and improve clinicia, confort.
-
The Steri-Mate handpiece with the lighted sleeve is steam sterlizeable which reduces the risk of cross contamination.
The Steri-Mate Handpiece Sleeve with LED Light is an accessory that easily slides over the Steri-Mate handpiece (predicate device) to generate a focused light to illuminate the clinician's working area during an ultrasonic procedure. The sleeve uses the energy generated from the Steri-Mate handpiece to generate light output when the ultrasonic unit's foot control is activated.
The provided text is a 510(k) summary for a medical device called "Steri-Mate Handpiece Sleeve with LED Light." This document describes the device, its intended use, and its technological characteristics, along with regulatory correspondence. However, it does not contain information about acceptance criteria, specific device performance numbers, or detailed study methodologies (like sample sizes, ground truth establishment, or expert qualifications) that would typically be found in a clinical study report.
Therefore, I cannot provide a table of acceptance criteria vs. reported device performance or other detailed study information asked for in your prompt because that specific information is not present in the provided text.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Steri-Mate Handpiece for Cavitron JET Unit, K941392) based on the prior use of components, performance data (not detailed in this section), and biocompatibility data.
Here's what I can extract and what is explicitly missing:
Missing Information Summary:
The provided text does not contain the following details required to answer your prompt fully:
- Quantitative Acceptance Criteria: There are no specific numerical thresholds or performance targets mentioned for the device.
- Reported Device Performance: While "performance data provided" is mentioned, the actual data or metrics are not detailed in this summary.
- Study Details: There is no description of any specific study (e.g., clinical trial, pre-clinical study, or validation study) with methodologies, sample sizes, ground truth establishment, expert involvement, or adjudication methods.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No mention of such a study.
- Standalone Performance: No mention of specific standalone algorithm performance (as this is a physical device, not an AI algorithm).
- Training Set Information: No information about a training set, as this is not an AI/machine learning device.
Based on the provided text, here is what can be inferred or explicitly stated:
This device is a physical accessory (a sleeve with an LED light) for an existing dental handpiece, not an AI or software device that would typically involve extensive performance metrics, ground truth, or expert review in the way your prompt implies for AI/diagnostic devices. The "performance data" mentioned would likely pertain to aspects like light output, durability, and ergonomic benefits, which are not quantified here.
The "study" referenced implicitly in the 510(k) process is the demonstration of substantial equivalence to a predicate device (K941392). This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
Key points from the text related to "proof" and "criteria":
- Safety and Effectiveness Justification: The manufacturer states, "We believe that the prior use of the components of the Steri-Mate Handpiece Sleeve with LED Light in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the Steri-Mate Handpiece Sleeve with LED Light for the indicated uses."
- Biocompatibility Testing: The device "passed biocompatibility testing for L929 MEM Elution Test - ISO, Oral Irritation Test - Acute Exposure - ISO and Kligman Maximization Test - ISO." These are the specific "acceptance criteria" and "study" (tests) mentioned in the document.
Reformatted information based on your request, highlighting missing data:
| Information Type | Device: Steri-Mate Handpiece Sleeve with LED Light |
|---|---|
| 1. Table of Acceptance Criteria and Reported Device Performance | Acceptance Criteria (Implied by biocompatibility) |
| * L929 MEM Elution Test - ISO: Passed | |
| * Oral Irritation Test - Acute Exposure - ISO: Passed | |
| * Kligman Maximization Test - ISO: Passed | |
| Reported Device Performance (from text, not quantitative) | |
| * Provides illumination to enhance visibility. | |
| * Soft tapered grip provides multiple pinch points, enhances ergonomics, and improves clinician comfort. | |
| * Steam sterilizable, reduces risk of cross-contamination. | |
| (Note: Quantitative performance metrics for illumination, ergonomics, or comfort are not provided in this summary. "Performance data provided" is mentioned generally but not detailed.) | |
| 2. Sample size and data provenance (test set) | Not applicable/Not provided for a typical "test set" as for an AI device. The referenced biocompatibility tests would have their own sample sizes for biological samples, but these are not disclosed. |
| 3. Number of experts and qualifications (ground truth for test set) | Not applicable. Ground truth in the context of an AI device is not relevant here. Biocompatibility tests are standardized laboratory procedures, not dependent on expert consensus on "ground truth." |
| 4. Adjudication method (test set) | Not applicable. This concept belongs to studies where human readers or algorithms make assessments that need to be adjudicated against a ground truth. This is a physical medical device. |
| 5. MRMC comparative effectiveness study and effect size | No. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks. This device is an accessory with an LED light, not a diagnostic AI. |
| 6. Standalone performance (algorithm only) | No. This is a physical device, not an algorithm. |
| 7. Type of ground truth used | Not applicable in the context of typical diagnostic AI ground truth (pathology, outcomes, expert consensus). For biocompatibility, the "ground truth" is the established scientific methods and pass/fail criteria of the ISO tests. For the general device, "ground truth" would relate to its physical properties meeting their design specifications and being safe for intended use, which is assessed through various engineering and safety tests, not detailed here beyond biocompatibility. |
| 8. Sample size for the training set | Not applicable. There is no "training set" as this is not an AI/machine learning device. |
| 9. How the ground truth for the training set was established | Not applicable. There is no "training set" for this physical device. The safety and effectiveness are established through reference to predicate devices, material biocompatibility, and likely other engineering tests (e.g., light output, durability, sterilization efficacy) which are generally summarized as "performance data provided" in the 510(k) without specific detail in this summary. |
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SECTION 5: 510(In) SUMMARY
MAY - 2 2007
DENTSPLY Internation Susquehanna Commerce Center We 221 West Philadelphia Street, Suite York, PA 17405-08
| CONTACT: | Helen Lewis |
|---|---|
| ---------- | ------------- |
January 31, 2007 DATE PREPARED:
TRADE OR PROPRIETARY NAME: Steri-Mate Handpiece Sleeve with LED Light
CLASSIFICATION NAME: Scaler, Ultrasonic CLASSIFICATION: Class II REGULATION NUMBER: 21CFR 872.4850
PREDICATE DEVICES: Steri-Mate Handpiece for Cavitron JET Unit (CJ Handpiece), K 941392
DEVICE DESCRIPTION:
The Steri-Mate Handpiece Sleeve with LED Light is an accessory that easily slides over the Steri-Mate handpiece (predicate device) to generate a focused light to illuminate the clinician's working area during an ultrasonic procedure. The sleeve uses the energy generated from the Steri-Mate handpiece to generate light output when the ultrasonic unit's foot control is activated.
INTENDED USE:
- Provides illumination to enhance visibility in the clinical working area during ultrasonic scaling procedures with the Steri-Mate handpiece. 2. When the lighted sleeve is installed on the Steri-Mate handpiece, the soft tapered grip provides multiple pinch points, to enhance ergonomics and improve clinician comfort. 3, The Steri-Mate handpiece with the lighted sleeve is steam sterilizeable which reduces the risk of cross contamination.
TECHNOLOGICAL CHARACTERISTICS:
All of the components found in Steri-Mate Handpiece Sleeve with LED Light have been used in legally marketed devices and/or were found safe for dental use. The Steri-Mate Handpiece Sleeve with LED Light has been evaluated and passed biocompatibility testing for L929 MEM Elution Test - ISO, Oral Irritation Test - Acute Exposure - ISO and Kligman Maximization Test -180
We believe that the prior use of the components of the Steri-Mate Handpiece Sleeve with LED Light in legally marketed devices, the performance clata provided, and the biocompatibility data provided support the safety and effectiveness of the Steri-Mate Handpiece Sleeve with LED Light for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2007
Ms. Helen Lewis Director of Corporate Compliance & Regulatory Affairs DENTSPLY International, Incorporated 221 West Philadelphia Street, Suite 60 Susquehanna Commerce Center York, Pennsylvania 17404
Re: K070307
Trade/Device Name: Steri-Mate Handpiece Sleeve with LED Light Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 31, 2007 Received: February 1, 2007
Dear Ms. Lewis:
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.
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Page 2 -Ms. Lewis
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.
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), please contact the Office of Compliance at (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runnes
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE
510(k) Number (if known): K6 703017
Device Name: Steri-Mate Handpiece Sleeve with LED Light
Indications for Use:
The Steri-Mate Handpiece Sleeve with LED Light is indicated for:
-
Provides illumination to enhance visibility in the clinical working area during ultrasonic scaling procedures with the Steri-Mate handpiece.
-
When the lighted sleeve is installed on the Steri-Mate handpiece, the soft tapered grip provides multiple pinch points, to enhance ergonomics and improve clinicia, confort.
-
The Steri-Mate handpiece with the lighted sleeve is steam sterlizeable which reduces the risk of cross contamination.
Susan Rumer
f Anesthesiology, General Hospital,
Control, Dental Devices
) Number: K070507
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.