Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are airpowered highspeed dental handpieces with intended use of preparing dental cavities for restorations, such as fillings, reducing hard tooth structure, and cleaning teeth. Karam STD, Karam Mini, AeroBreeze STD, and AeroBreeze Mini can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. Karam ECN model connects directly to either Type A or Type B hose connectors and does not require a coupling.

Karam45 and Dexor45 are air-powered highspeed dental handpieces with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. Both models can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling.

Device Description

The devices are an air-powered dental handpieces intended for use with a friction-grip bur that conforms to ISO 1797-1 standard. Recommended air pressure is 29 ~ 36 psig (gage pressure) to produce high-speed bur rotation ranging between 380,000 and 450,000 RPM. Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are straight-headed. Karam45 and Dexor45 models are designed with a 45-degree back angle. The devices include a water line that directs water mist/jet to the cutting area for cooling and irrigation.

Aerobine line of handpieces employs a cartridge type air turbine with a common core design across the product line. All models employ a friction-grip push button chuck, a drive air line, a discharge air egress line, a water delivery line to supply cooling water. With the exception of Karam ECN, all models can be used with either Karam 4B or Karam 2A coupling. Karam ECN connects directly to Type A or Type B hose connectors without a coupling.

AI/ML Overview

The provided text describes Aerobine Line of Dental Handpieces and compares them to predicate devices for a 510(k) submission. It does not contain a detailed study with acceptance criteria and reported device performance in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics.

Therefore, many sections of your request cannot be fully answered.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document lists "Minimum Performance requirements" as a technological characteristic and states that the Aerobine devices are "Identical" to the predicate devices for these requirements. However, it does not specify the quantitative acceptance criteria or the actual reported performance values for the Aerobine devices.

Acceptance Criteria	Reported Device Performance (Aerobine Line of Dental Handpieces)
Speed range	Identical to predicate devices (K062740 and K972376)
Stall torque	Identical to predicate devices (K062740 and K972376)
Cooling water flow rate	Identical to predicate devices (K062740 and K972376)
Noise level	Identical to predicate devices (K062740 and K972376)
Bur extraction force	Identical to predicate devices (K062740 and K972376)
Eccentricity	Identical to predicate devices (K062740 and K972376)
Sterility (Autoclave up to 135°C 15 minutes at 134°C)	Unknown (for Karam STD/Mini/ECN, AeroBreeze STD/Mini vs. K062740)
Sterility (Autoclave up to 135°C 15 minutes at 134°C)	Autoclave up to 135°C 20 minutes at 135°C (for Karam45, Dexor45 vs. K972376)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "engineering analysis results obtained in support of the sterilization validation effort (section 14)," but section 14 is not included, and no details about specific test sets, sample sizes, or data provenance are mentioned for performance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document does not describe a study involving expert assessment or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This information is not applicable/not provided. The device is an air-powered dental handpiece, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/not provided. The document indicates that substantial equivalence was determined based on "technological profile comparisons (Table 1) and engineering analysis results."

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not provided. There is no mention of a "training set" or ground truth establishment in this context.

Summary

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Aerobine, Inc. 7670 Opportunity Rd. Suite 100
San Diego, CA 92111

مراهم م

・、

Image /page/0/Picture/1 description: The image shows the word "AEROBINE" in bold, sans-serif font. Above and below the word are curved lines that form a circle around the word. The curved lines are thicker than the letters in the word.

Tol) 858–277–1700
Fax) 858–571–7383

www.aerobine.com info@aerobine.com

163

5 510(k) SUMMARY

K101717

AUG 2 0 2010

Aerobine Line of Dental Handpieces

Submitted by:	Aerobine, Inc.7670 Opportunity Rd. Suite 100San Diego, CA 92111
Contact Person:	Yong W. Kim, PresidentTel: 858-277-1700Cell: 858-382-8526Fax: 858-571-7383 email: ywkim@aerobine.com
Date of Summary:	March 9, 2010
Common name:	Air-powered Dental Handpiece
Device name:	Aerobine Line of Dental Handpieces: Karam STD, Karam Mini, Karam ECN,AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45, Karam 4B coupling,Karam 2A coupling
Classification:	Dental Handpiece and AccessoriesClass I Medical Device: 21 CFR 872.4200Product Code: EFBPanel 72
Predicate Devices:	JINDELL Highspeed Air Turbine Handpiece (K062740)Product Code: EFBIMPACT Air 45 Handpiece for Periodontal Use (K972376)Product Code: EFB

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Aerobine, Inc. 7670 Opportunity Rd. Suite 100 San Diego CA 92111

K101717

Tel) 858-277-1700
Fax) 858-571-7383

5.1 Device Description

5.2 Indications for use

5.3 Description of device design

Conclusions from Technical Comparisons with predicate devices 5.4

Based on technological profile comparisons (Table 1) and engineering analysis results obtained in support of the sterilization validation effort (section 14), we conclude:

Aerobine Handpieces, Karam STD/Mini/ECN, AeroBreeze STD/Mini are substantially equivalent to the predicate device (K062740) in terms of their intended use, operating principles, performance, material compositions, and sterilization characteristics.
Aerobine Handpieces, Karam45, Dexor45 are substantially equivalent to the predicate device -(K972376) in terms of their intended use, operating principles, performance, material compositions, and sterilization characteristics.

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K101717

AEROBINE

3073

kerobine, Inc.
1670 Opportunity Rd. Suite 100
San Diego, CA 92111

ﺮ ﮐ

Tel) 858-277-1700 Fax) 858-571-7383

www.aerobine.com info@aerobine.com

Aerobine Line of Dental Handpieces (Model: Karam STD, Karam Mini, Karam ECN, -AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45, Karam 4B coupling, Karam 2A coupling) are both safe and effective for their intended use.

Table 1 Technological Characteristics Comparisons

TechnologicalCharacteristics	KaramSTD/Mini/ECN,AeroBreeze STD/Mini	Comparisonto PredicateDevice(K062740)	Karam45. Dexor45	Comparison toPredicate Device(K972376)
Indication ForUse	For restoration andcavity preparation	Identical	For surgical proceduressuch as 3rd molar removal	Identical
Energy source	Compressed air	Identical	Compressed air	Identical
Design	Cartridge type turbine,friction-grip push-buttonchuck, cooling waterdelivery system,couplings	Identical	Cartridge type turbine,friction-grip push-buttonchuck, cooling waterdelivery system,couplings, rear air bleedfor improved infectioncontrol	Identical Except:non-catridge typeturbine
MinimumPerformancerequirements	Speed range, stalltorque, cooling waterflow rate, noise level,bur extraction force,eccentricity	Identical	Speed range, stall torque,cooling water flow rate,noise level, bur extractionforce, eccentricity	Identical
Standards met	EN ISO 7785-1ISO 9168ISO 1797-1	Identical	EN ISO 7785-1ISO 9168ISO 1797-1	Identical
Composition ofMaterials	Stainless steel,aluminum alloy, copperalloy, chrome plating,nickel plating, elastomer	Identical	Stainless steel, aluminumalloy, copper alloy,chrome plating, nickelplating, elastomer	Identical
Biocompatibility	Constructed from usualand common materialsknown to the industry	Identical	Constructed from usualand common materialsknown to the industry	Identical
Sterility	Autoclave up to 135°C15 minutes at 134 °C	Unknown	Autoclave up to 135°C15 minutes at 134 °C	Autoclave up to135°C20 minutes at 135°C
Electrical Safety	No electrical connection	Identical	No electrical connection	Optional fiber-optic
Chemical Safety	Used corrosion-resistantmaterials, free ofchemical hazard	Identical	Used corrosion-resistantmaterials, free ofchemical hazard	Identical

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes stacked vertically.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Aerobine, Incorporated C/O Ms. Paula Wilkerson Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

AUG 2 0 2010

Re: K101717

Trade/Device Name: Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45, Karam 4B coupling, and Karam 2A coupling Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: August 5, 2010 Received: August 6, 2010

Dear Ms. Wilkerson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2- Ms. Wilkerson

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Aerobine, Inc. 7670 Opportunity Rd. Suite 100 San Diego, CA 92111

K101717

AEROBINE

Tel) 858-277-1700
Fax) 858-571-7383

.aerobine.com
info@aerobine.com

Indications for Use 4

510(k) Number (if known):

Device Names: Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, AeroBreeze Mini, Karam45, Dexor45. Karam 4B coupling, and Karam 2A coupling

Indications For Use:

Prescription Use	X AND/OR Over-The-Counter Use ______
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(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

signature

Concurrence of CDRH, Office of Device Evaluation (ODE)(Division Sign-Off)	Division of Anesthesiology, General HospitalInfection Control, Dental Devices
Page 1 of 1

4-1
	Number: K101717

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.