(171 days)
No
The description focuses on the device's function as a utility supply and interface for dental tools, with no mention of AI or ML capabilities.
No
The device is described as an operative unit that supplies utilities for dental tools and accessories, not directly as a device for treatment. Its function is to provide an interface for other dental instruments, not to perform therapeutic actions itself.
No.
The device description indicates that it is a dental operative unit that provides utilities and serves as a base for dental tools, rather than performing diagnostic functions.
No
The device description clearly states it is a "dental operative unit" that provides utilities like air, water, suction, drain, and electricity, and includes controls for water flow and preset air pressure. These are physical components and functions, not solely software.
Based on the provided information, the Cocoon® Hygienist is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that it's a dental operative unit intended to supply utilities to and serve as a base for dental tools and accessories for use by dental professionals. This describes a device used in vivo (on a living patient) during dental procedures, not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details how it provides utilities like air, water, suction, and electricity to dental instruments. This aligns with the function of a dental chair unit, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any features related to analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on such analysis.
- Predicate Device: The predicate device listed (K020833 Boyd Delivery Units) is also a dental delivery unit, further supporting its classification as a dental operative device, not an IVD.
In summary, the Cocoon® Hygienist is a piece of dental equipment used to support dental procedures performed on patients, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Cocoon® Hygienist is a dental operative unit intended to supply utilities to and serve as a base for dental tools and accessories for use by dental professionals.
Product codes
EIA
Device Description
The Cocoon Hygienist is a dental operative unit that provides the dentist with primary requirements for dental operations. The delivery system is designed to be used as an interface device to connect the dental operating hand instruments to the appropriate supply utilities such as air, water suction, drain, and electricity. The unit is supplied with controls that allow the dentist. dental hygienist, or operator to set the water flow to the hand pieces. The water flow of the syringe, directly connected to main water supply, depends on the input water pressure. The output air pressure is preset in the unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Pascal Dupevron Regulatory Affairs
8. SMDA Summary of Safety and Effectiveness - "510(k) Summary"
- A. Submitter Information
SATELEC Z.1. du Phare, BP 216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE
Telephone: 011 33 5 5634 0607
Contact Person:
Date Prepared: February 25, 2004
- B. Device Identification
| Common/Usual Name: | Delivery System |
|---|---|
| Proprietary Name: | Cocoon Hygienist |
C. Identification of Predicate Devices
The Cocoon Hygienist is substantially equivalent to the predicate device by Boyd Industries, Inc., Boyd Delivery Units (K020833) previously cleared by FDA and currently marketed.
D. Device Description
The Cocoon Hygienist is a dental operative unit that provides the dentist with primary requirements for dental operations. The delivery system is designed to be used as an interface device to connect the dental operating hand instruments to the appropriate supply utilities such as air, water suction, drain, and electricity. The unit is supplied with controls that allow the dentist. dental hygienist, or operator to set the water flow to the hand pieces. The water flow of the syringe, directly connected to main water supply, depends on the input water pressure. The output air pressure is preset in the unit.
The intended use of the Satelec Cocoon Hygienist is to supply utilities to and serve as a base for dental tools and accessories for the dental professional.
E. Substantial Equivalence:
The technical characteristics of the Cocoon Hygienist are almost identical to those of the Boyd Industries Inc., Dental Operative Units (K020833). Differences that exist between the systems relating to technical specifications, materials, physical appearance, and control systems are minor and do not affect the relative safety or effectiveness of the Cocoon Hygienist.
: 行 :
1
Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2004
Satelec C/O Dr. Jean-Luc Boulnois President Interactive Consulting, Incorporated 70 Walnut Street Wellesley, Massachusetts 02481
Re: K040529
Trade/Device Name: Cocoon® Hygienist Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: August 10, 2004 Received: August 11, 2004
Dear Dr. Boulnois:
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.
2
Page 2 - Ms. Boswell
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
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
3
510(k) Number (if known):
Ko40529
Device Name: Cocoon® Hygienist
Indications for Use:
The Cocoon® Hygienist is a dental operative unit intended to supply utilities to and serve as a base for dental tools and accessories for use by dental professionals.
Please refer to the attached listing for a complete description.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Romano
n of Anesthesiology, General Hospital. Infection Control Dental D
510(k) Number: J(040526
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use