The AHP-101 fully autoclavable, straight, 1:1 ratio E-Type dental handpiece is intended for use in general dentistry procedures, such as removing carious material from the dentine.

Device Description

The AHP-101 is a straight, fully autoclavable, 1:1 ratio E-Type dental handpiece intended for use in general dentistry procedures. It accepts standard 2.35mm (3/32") burs and may be used with prophy angles.

AI/ML Overview

This document is a 510(k) summary for a dental handpiece (AHP-101 E-Type Straight Handpiece). As such, it reports on a determination of substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific performance acceptance criteria.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable in the context of this 510(k) submission.

Here's why and what information is provided:

510(k) process: A 510(k) submission demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing similar technological characteristics and indications for use, often without requiring new clinical studies or the establishment of new, specific performance acceptance criteria in the same way a PMA (Pre-Market Approval) would.
Reliance on predicate device: The AHP-101 is deemed substantially equivalent to Aseptico's AHP-64 Handpiece [510(k) K020137]. The predicate device would have been evaluated for its safety and effectiveness, and the general understanding is that if the new device is substantially equivalent, it too is safe and effective for its intended use.

However, the document does list features of substantial equivalence which can be reinterpreted as a form of "acceptance criteria" based on similarity to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (AHP-101)
Intended Use: General dentistry procedures	Intended for general dentistry procedures
Compatibility: Fits all E-type dental handpiece motors	Fits all E-type dental handpiece motors
Sterilization: Fully autoclavable	Fully autoclavable. Independently validated sterility assurance level (SAL) of 10⁻⁶
Design: Straight, 1:1 gear-ratio design	Straight, 1:1 gear-ratio design
Input Speed Range: Up to 30,000 RPM	0 - 30,000 RPM input speed range
Construction Materials: Stainless steel, brass, and anodized aluminum	Constructed of stainless steel, brass, and anodized aluminum
Standards Compliance: Complies with applicable portions of relevant ISO standards	Complies with applicable portions of ISO 7785-2:1995, ISO 3964:1982, ISO 11134:1994, AAMI TIR No. 12-1994

Regarding the other requested information:

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study that involved a test set in the traditional sense of evaluating performance. The "test" involved demonstrating equivalence to a predicate device. The validation of the sterility assurance level (SAL) of 10⁻⁶ would have involved a specific, industry-standard sterilization validation study, but the details (sample size, provenance) are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The 510(k) process relies on demonstrating equivalence, not on establishing a new ground truth through expert consensus for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental handpiece, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mechanical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the purpose of the 510(k), the "ground truth" is the established safety and effectiveness of the predicate device (Aseptico's AHP-64 Handpiece). The AHP-101 essentially relies on the predicate's established performance based on its original clearance and compliance with recognized standards.
8. The sample size for the training set: Not applicable. There is no machine learning or AI training set involved.
9. How the ground truth for the training set was established: Not applicable.

Summary

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3 2005 MAY

Image /page/0/Picture/2 description: The image shows a logo for "ASEPTICO International". The logo is in a stylized font, with the word "ASEPTICO" in a larger font size than the word "International". The logo is in black and white, and the text is slightly distorted.

Aseptico Inc. · 8333 216" St SE · Woodinville, WA 98072

Telephone: (425) 487-3157 Fax: (360) 668-8722 Web: www.aseptico.com E-mail: grant(@aseptico.com

510(k) Summary

Contact: Grant Ramaley

Date Prepared: April 11, 2005

Trade or Proprietary Name: AHP-101 E-Type Straight Handpiece

Classification Name: 872.4200 Dental Handpiece and Accessories

510(k) Number:

Device Description:

Features of Substantial Equivalence to Aseptico's AHP-64 Handpiece [510(k) K020137]

Intended for general dentistry procedures 1)
Fits all E-type dental handpiece motors 2)
Fully autoclavable. Independently validated sterility assurance level (SAL) of10° 3)
Straight, 1:1 gear-ratio design 4)
1. 0 30,000 RPM input speed range
1. Constructed of stainless steel, brass, and anodized aluminum
1. Complies with applicable portions of the following standards: ISO 7785-2:1995, ISO 3964:1982, ISO 11134:1994, AAMI TIR No. 12-1994

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Image /page/1/Picture/3 description: The image shows a date, "MAY - 3 2005". The month is MAY, the day is 3, and the year is 2005. The text is in a simple, sans-serif font and is easy to read.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aseptico, Incorporated C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K051077

Trade/Device Name: AHP-101 E-Type Straight Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: April 25, 2005 Received: April 27, 2005

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nated 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 approvisions 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 (1 Wri), It may of bagges in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device of the read may publish further announcements concerning your device in the Federal Register

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Page 2 - Mr. Lehtonen

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease to advised that 12 a determination that your device complies with other requirements mount that I Drima mires and regulations administered by other Federal agencies. or the rice of any - outh all the Act's requirements, including, but not limited to: registration 1 ou intist comply with a807); labeling (21 CFR Part 801); good manufacturing practice and fisting (2) 22 x 1 forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as betronic 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) This letter will and in you The FDA finding of substantial equivalence of your device to a premaired predicated. 22 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), rr you desire spocitiv at . 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,

Jenette G. Michie Oms.

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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Indications for Use

510(k) Number (if known): KSS1077

Device Name: AHP-101 E-Type Straight Handpiece

Indications for Use:

The AHP-101 fully autoclavable, straight, 1:1 ratio E-Type dental handpiece is THE Arlin "To Fraily datestal dentistry procedures, such as removing carious material from the dentine.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulvey for MSR

on of Anesthesiology, General Hospital, ection Control, Dental Devices

Number. K051017

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.