The Boyd Delivery Unit is a Dental Operative Unit that provides the dentist with primary requirements for a dental operatory. The delivery system is designed to be used as an interface device to connect the dental operatory hand instruments to the appropriate supply utility such as air, water suction, drain and electricity. It functions as a system management device that provides a method of operating various hand instruments from a single control input device. The unit is furnished with controls that allow the dentist or operator to set the air pressure and water flow to the hand pieces and the syringe in the delivery head. The unit is of a stackable design providing a base for dental tools and accessories. Assistant's instrumentation delivery system, water heater, and the cuspidor are all features that this unit can offer.

AI/ML Overview

This 510(k) summary describes a traditional device submission and does not include an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics is not present in the provided text. The document is for a dental operative unit and focuses on substantial equivalence to predicate devices based on design and intended use, rather than performance metrics derived from a study.

The FDA 510(k) clearance process for this type of device does not typically require performance studies with the level of detail requested for AI/ML products. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's an breakdown of the available information, noting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in the provided context. The submission focuses on comparing features and intended use to predicate devices, not on quantitative performance metrics or specific acceptance criteria met through a study.

2. Sample Size for Test Set and Data Provenance:

Not applicable. There is no mention of a "test set" in the context of a performance study. The comparison is feature-based against existing commercial products.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. "Ground truth" is typically relevant for diagnostic or classification tasks, which are not described for this device.

4. Adjudication Method:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. No MRMC study was conducted or mentioned, as this is not an AI/ML device.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is not an algorithm-only device.

7. Type of Ground Truth Used:

Not applicable.

8. Sample Size for the Training Set:

Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of Device Comparison (from the provided text, which serves as the "study" for substantial equivalence):

The provided text includes a "Comparison of device to marketed device" table. This table serves as the primary "study" or justification for substantial equivalence for this type of medical device submission. It outlines various features of the Boyd Delivery Unit and compares them to three predicate devices (a-dec, DentalEZ, Marus Dental).

Acceptance Criteria (Implicitly based on comparison):

The implicit acceptance criterion for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices. This means the Boyd Delivery Unit must be shown to be as safe and effective as the predicate devices, with no new questions of safety or effectiveness raised.

Reported Device Performance (as demonstrated by comparison):

The table highlights the following for the Boyd Industries, Inc. device:

Mounting unit: Cabinet (matches a-dec, DentalEZ, Marus Dental)
Instruments Available: High-speed handpiece hookup, low-speed handpiece hookup, 3-way syringe, saliva ejector, high volume evacuation with solids collector (matches or is very similar to all predicates)
Activation: Master off/on valve, handpiece toggle switch and foot control. This is similar to DentalEZ, and differs slightly from a-dec (which lacks "master off/on valve" in the description) and Marus Dental (which has "Automatic activation for each handpiece"). The differences are not presented as raising new safety or effectiveness concerns, but rather as variations in control mechanisms common to such devices.
Cleaning: Air flush system. This is a point of difference with the predicates, which use "Water flush." The applicant implicitly argues this difference does not impact substantial equivalence or raise new safety/effectiveness questions, likely because both are established cleaning methods for dental units.
Water System: Self contained. Similar to a-dec, and one option for DentalEZ, while Marus Dental uses "City hook up."

Conclusion of the FDA Letter ({2} and {3}):

The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This indicates that the comparison presented in the table was sufficient to demonstrate that the device met the implicit acceptance criterion of being as safe and effective as the predicates.

Summary

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510(k) SUMMARY

1. Boyd Industries, Inc. 12900 44th Street North Clearwater, FL 33762 US Phone: 727-561-9292 Fax: 727-561-9393 Contact: Bruce Livingston Establishment Registration Number: 1062917 (reference next page) Date of Submission: March 8, 2002
1. Trade Name: Boyd Delivery Units Common Name: Delivery System Classification Name: Dental Operative Unit and Accessories
1. Equivalent Device:

The Boyd Delivery Unit is substantial to similar Dental Operative Unit and Accessories previously cleared with the FDA for marketing in the United States, using the same basic technology, design process and attention to safety. Copies of product literature are included in Section 1 and Comparison Data is included in section 2 of this submittal.

1. Technical Description:
  The Boyd Delivery Unit is a Dental Operative Unit that provides the dentist with primary requirements for a dental operatory. The delivery system is designed to be used as an interface device to connect the dental operatory hand instruments to the appropriate supply utility such as air, water suction, drain and electricity. It functions as a system management device that provides a method of operating various hand instruments from a single control input device. The unit is furnished with controls that allow the dentist or operator to set the air pressure and water flow to the hand pieces and the syringe in the delivery head. The unit is of a stackable design providing a base for dental tools and accessories. Assistant's instrumentation delivery system, water heater, and the cuspidor are all features that this unit can offer.
1. Intended use. The Boyd Delivery Unit is intended to supply utilities to and serve as a base for dental tools and accessories. The use of this device does not differ significantly from the predicate dental operative units.

6) Comparison of device to marketed devices

Reference chart "Comparison of device to marketed devices" on the following page.

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isting from FDA Websit Ticial Correspondent Name: MR. BRUCE LIVING:
Toial Correspondent Phone: Number: 727-561-929
Torial Correspondent Phone: Number: 727-561-9299
000-44TH STREET, INC.
EARWATER, F Setablishment Names
2900 44TA STREET NYON
2017 ATTA STREET NYON
CLEAR ANTAL STREET NYONE Nomber: 10629 17
Stablishment Operationa: Commont Manufactu
Sate of Rugustionar: Cont Owner/Operator:
BOYD INDUSTRUES, INC.
I2900 44TH STRIEST NORTH
CLEARWATERS FLE 33722
CLEARWATERS, FL 33722
Owner/Operator Number: 90303

omparison of device to marketed device

Feature	Boyd Industries, Inc.	a-dec (K000966)	DentalEZ (K931204)	Marus Dental
Mounting unit	Cabinet	Cabinet	Cabinet	Cabinet
InstrumentsAvailable	High-speed handpiece hookup, lowspeed handpiece hookup, 3-waysyringe, saliva ejector, high volumeevacuation with solids collector	High-speed handpiece hookup, lowspeed handpiece hookup, 3-waysyringe, saliva ejector, high volumeevacuation with solids collector	High-speed handpiece hookup, lowspeed handpiece hookup, 3-waysyringe, saliva ejector, high volumeevacuation with solids collector	High-speed handpiece hookup, lowspeed handpiece hookup, 3-waysyringe, saliva ejector, high volume.
Activation	Master off/on valve, handpiecetoggle switch and foot control	handpiece toggle switch and footcontrol	Master off/on valve, handpiecetoggle switch and foot control	Automatic activation for eachhandpiece
Cleaning	Air flush system	Water flush	Water flush	Water flush
Water System	Self contained	Self contained	City hook up or self contained	City hook up

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 8 2002

Mr. Bruce Livingston Boyd Industries, Incorporated 12900 44th Street North Clearwater, Florida 33762

Re: K020833

Trade/Device Name: Boyd Delivery Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: June 14, 2002 Received: June 27, 2002

Dear Mr. Livingston:

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.

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.

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Page 2 - Livingston

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Ulatsowski

A. Ulatowski Timot 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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33

Pege. ........................................................................................................................................................................

510(k) Number (if known)

Device Name:

Indications For Use:

Boyd delivery systems are intended for use by Dental Professionals for effective treatment of patients.

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

Concurence of CDRH, Office of Device Evaluation (ODF)

Prescription Usey (Per 21 CFR 801,109)

Over-The-Counter Use

(Optional Format 1-2-96)

Swar Rumpie

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Oractrol Devices Division of Anesthesionsy, Dental Devices

510(k) Number. K020833

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.