(143 days)
LUBRINA HIM-1 is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.
NOTE: LUBRINA HIM-1 should be used only with pre-cleaned dental handpieces and before they are sterilized.
CAUTION: FEDERAL (US) law restricts the use of this device to licensed professionals.
The LUBRINA HIM-1 is the maintenance system for handpieces, consisting of a main body and several accessories.
The main body is constructed in a box on which the maximum 4 pieces of handpieces are able to be connected by each connection nut, and two spray cans are set inside the box.
This 510(k) submission for the LUBRINA HIM-1 device does not explicitly describe a study with acceptance criteria and reported device performance in the way typically expected for a new medical device claiming performance characteristics related to diagnostic or treatment efficacy.
Instead, this submission is a Premarket Notification (510(k)) which aims to demonstrate substantial equivalence to already legally marketed predicate devices. For Class I devices like this one, the focus is on showing that the new device has "similar general intended uses, similar principles of operation, and similar technological characteristics" to existing devices, and that any differences do not raise new questions of safety or effectiveness.
Therefore, the requested information elements related to acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are largely not applicable or directly available in this type of submission.
Here's a breakdown of what can be inferred or stated based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the nature of a 510(k) for a Class I device focused on substantial equivalence, there are no explicit quantitative acceptance criteria or detailed performance reports for metrics like sensitivity, specificity, or outcomes. The "acceptance criteria" here are inherently tied to demonstrating similarity to predicate devices.
| Characteristic | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Indication for Use | Must be identical or nearly identical to predicate devices | Identical to predicate devices |
| Target Population | Must be identical or nearly identical to predicate devices | Identical to predicate devices |
| Design | Must be similar to predicate devices, without raising new safety/effectiveness concerns | Similar to predicate devices |
| Materials | Must be identical or similar to predicate devices, with no new safety/effectiveness concerns | Identical to predicate devices |
| Performance | Must be similar to predicate devices, achieving the same intended function adequately | Similar to predicate devices |
| Sterility | Must be identical to predicate devices (likely referring to the non-sterile nature of the device itself, but used with pre-cleaned instruments) | Identical to predicate devices |
| Biocompatibility | Must be identical to predicate devices (likely meaning non-biocompatibility concerns given the device's function and lack of patient contact) | Identical to predicate devices |
| Mechanical Safety | Must be identical or similar to predicate devices, meeting established safety standards | Identical to predicate devices |
| Chemical Safety | Must be identical or similar to predicate devices, meeting established safety standards | Identical to predicate devices |
| Anatomical Sites | Must be similar to predicate devices (i.e., external maintenance of dental instruments, not used on anatomical sites) | Similar to predicate devices |
| Human Factors | Must be similar to predicate devices, with no new usability issues | Similar to predicate devices |
| Energy Used/Delivered | Must be similar to predicate devices | Similar to predicate devices |
| Compatibility with Environment and Other Devices | Must be similar to predicate devices | Similar to predicate devices |
| Where Used | Must be identical to predicate devices (i.e., in a dental office, separate from patient) | Identical to predicate devices |
| Standards Met | Must be similar to predicate devices (indicating compliance with relevant industry standards for safety, etc.) | Similar to predicate devices |
| Electrical Safety | Must be similar to predicate devices, meeting established safety standards | Similar to predicate devices |
| Thermal Safety | Must be similar to predicate devices, meeting established safety standards | Similar to predicate devices |
Study Description:
The document describes a substantial equivalence comparison rather than a traditional performance study. The core "study" is the comparison against predicate devices to demonstrate that the LUBRINA HIM-1 performs its intended function similarly and safely.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. There is no "test set" in the sense of a dataset for algorithmic performance evaluation. The "sample" here refers to the LUBRINA HIM-1 device itself, which is compared to existing predicate devices.
- Data Provenance: The comparison is based on the characteristics of the LUBRINA HIM-1 and two predicate devices (KaVo QUATTROcare and W & H Assistina), both of which are already marketed in the USA. The manufacturer of LUBRINA HIM-1 is J. MORITA MFG. CORP. in Kyoto, Japan. This is a comparison of product specifications and functions, not a clinical data review. It is not framed as retrospective or prospective data collection from patients or specific device usage tests requiring datasets.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. There is no "ground truth" to establish for a test set in this context. The evaluation is based on engineering specifications, intended use, and general performance characteristics compared to existing devices.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is not relevant for a Class I device like a dental handpiece maintenance system aiming for substantial equivalence. MRMC studies are typically for diagnostic imaging devices or treatment efficacy where human reader performance is a critical factor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is a mechanical/electronic system, not an algorithm.
7. The Type of Ground Truth Used:
Not applicable in the conventional sense of clinical performance studies. The "ground truth" for this substantial equivalence argument is the established safety and effectiveness of the predicate devices. The new device is deemed "safe and effective" because it is demonstrably similar to devices already found safe and effective by the FDA.
8. The Sample Size for the Training Set:
Not applicable. There is no machine learning or algorithmic component to this device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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Attachment-6
510(k) SUMMARY J. Morita USA Inc.'s Lubrina HIM~1
Submitter Name and Address with Phone/Fax : l.
MAY 3 1 2007
Registration No. 2081055 Initial Distributor: J. Morita USA, Inc. 9 Mason Irvine, CA 92618 USA 949-581-9600 Telephone: Facsimile: 949-581-9688
Registration No. 3002807636 Manufacturer: J. MORITA MFG. CORP. 680 Higashihama Minami-cho Fushimi-ku, Kyoto Japan 612-8533 +81-75-611-2141 +81-75-605-2354
Contact Person 2.
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
Date summary prepared: 3.
December 20, 2006
Device Name: 4.
| Common/Usual Name: | Dental handpiece accessory for maintenance, cleaning and lubrication |
|---|---|
| Trade or Proprietary Name: | LUBRINA |
| Product Model Name ; | HIM-1 |
| Regulation Number: | 21 CFR § 872.4200 |
| Regulation Name : | Dental handpiece and accessories |
| Regulatory Class : | I |
| Product Code: | EFB |
| Classification Panel: | 872 Dental. |
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5. Substantial Equivalency is claimed against the following device:
The LUBRINA HIM-1 is a maintenance system for handpieces, which is used in separate space apart from the patient and dentist. This is commonly used in dentistry, and the device is designed in a similar structure and performance.
· Predicate device
The HIM-1 is substantially equivalent to the Kavo QUATTROcare from KaVo America (K #012308) and the W & H Assistina from A-Dec, Inc. ( K #010127). The HIM-1 has similar general intended uses, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices.
Although there are minor differences in the characteristics between the HIM-1 and its predicate device, these differences do not raise new questions of safety or effectiveness.
Description of the device: 6.
The LUBRINA HIM-1 is the maintenance system for handpieces, consisting of a main body and several accessories.
The main body is constructed in a box on which the maximum 4 pieces of handpieces are able to be connected by each connection nut, and two spray cans are set inside the box.
7. Indications for use
LUBLINA HIM-1 is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.
LUBLINA HIM-1 should be used only with pre-cleaned dental handpieces NOTE: and before they are sterilized. CAUTION: FEDERAL(US) law restricts the use of this device to licensed professionals.
Safety and effectiveness of the device 8.
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison ( Section 9 at next page ).
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Substantial Equivalent comparison table 9.
K0012308 and K0010127. FDA file reference number 510k number
| TECHNOLOGICAL CHARACTERISTICS | Comparison result |
|---|---|
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Identical |
| Performance | Similar |
| Sterility | Identical |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Similar |
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, District of Columbia 20005 MAY 3 1 2007
Re: K070074
Trade/Device Name: LUBRINA HIM-1 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: May 21, 2007 Received: May 22, 2007
Dear Mr. Barritt:
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 - Mr. Barritt
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 moan mat r Dr mas mace a avtes and regulations administered by other Federal agencies. or the Act of any 1 ederal backed as a requirements, including, but not limited to: registration 1 ou must comply with an 07); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), labeling systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form in the quadistion 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) I mo reter will and in J . The FDA finding of substantial equivalence of your device to a promative month and 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), 11 you don't 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 may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suyite Y. Michael mD.
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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K070074
Indications for Use
510(k) Number (if known): Unknown
Device Name: LUBRINA HIM-1
Indications For Use:
LUBRINA HIM-1 is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.
NOTE: LUBRINA HIM-1 should be used only with pre-cleaned dental handpieces and before they are sterilized.
CAUTION: FEDERAL (US) law restricts the use of this device to licensed professionals.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR ·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Wuly for KSR
sion of Anesthesiology, General Hospital, Jaction Control, Dental Devices
10(k) Number
Page 1 of
§ 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.