(22 days)
The intended use of the dental instrument heater - The Down Pak - is to provide continuous heat and/or vibration at the tip of a dental instrument. The Down Pak is designed for processing gutta percha (softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment. The device may only be operated by dentists and endodontists.
The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.
The provided text describes a 510(k) summary for the "Down Pak" dental instrument, which is a battery-operated heater designed to provide continuous heat and/or vibration to the tip of a dental instrument for endodontic procedures. The document primarily focuses on demonstrating substantial equivalence to a predicate device ("EndoTwinn") and compliance with recognized consensus standards.
Based on the provided text, the following information can be extracted regarding acceptance criteria and device performance:
1. A table of acceptance criteria and the reported device performance:
The document states compliance with several international standards but does not provide specific quantitative acceptance criteria or detailed device performance metrics within the context of these standards. It generally asserts that the device "complies with the requirements of recognized consensus standards."
| Acceptance Criteria Category | Standard ID & Title | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1:1988 +A1. A2 (Medical electrical equipment - Part 1: General requirements for safety) | "The Down Pak complies with the requirements of recognized consensus standards" |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: 2001 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests) | "The Down Pak complies with the requirements of recognized consensus standards" |
| Risk Management | ISO 14971:2000 + A1 (Medical devices - Application of risk management to medical devices) | "The Down Pak complies with the requirements of recognized consensus standards" |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:1999 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) | "The Down Pak complies with the requirements of recognized consensus standards" |
| Biocompatibility (Irritation & Sensitization) | ISO 10993-10:2002 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) | "The Down Pak complies with the requirements of recognized consensus standards" |
It's important to note: The document does not provide specific numerical or qualitative performance results (e.g., "device maintained temperature within X range for Y duration") for any of these standards. It only states general compliance.
2. Sample size used for the test set and the data provenance:
The document does not specify a sample size for a test set that would typically be associated with clinical performance or direct device efficacy studies. The "Device Testing Results" section refers to compliance with consensus standards, which are often tested on individual units or small batches of devices for design verification rather than a large clinical test set.
Data provenance (country of origin, retrospective/prospective) is not mentioned in relation to any specific testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since a clinical test set with human subject outcomes or expert-adjudicated results is not described in this 510(k) summary, information regarding the number and qualifications of experts for ground truth establishment is not available.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
As no clinical test set requiring expert adjudication is described, the adjudication method is not applicable and therefore not mentioned.
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 document describes a dental instrument heater, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This device is a hardware instrument, not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the standards compliance mentioned (IEC, ISO), the "ground truth" would be the successful demonstration that the device design and manufacturing meet the technical specifications and safety requirements outlined in those standards (e.g., electrical parameters, biocompatibility test results). This is not typically "expert consensus," "pathology," or "outcomes data" in the clinical sense, but rather engineering and laboratory test results against established performance criteria within the standards.
8. The sample size for the training set:
The concept of a "training set" is relevant for machine learning or AI models. This document describes a physical medical device, not a software algorithm. Therefore, information regarding a training set sample size is not applicable and not provided.
9. How the ground truth for the training set was established:
As there is no training set mentioned (given the nature of the device), this information is not applicable and not provided.
In summary:
The provided 510(k) summary for the "Down Pak" dental instrument focuses on demonstrating substantial equivalence to a predicate device and compliance with established international consensus standards for medical devices (electrical safety, EMC, risk management, biocompatibility). It does not include details of clinical studies, expert-adjudicated test sets, or AI/algorithm performance metrics, as these are not relevant to the type of device being described. The "Device Testing Results" section refers to general compliance with these standards rather than specific quantitative performance criteria.
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Image /page/0/Picture/1 description: The image shows a close-up of a logo or label with the word "Twin" prominently displayed. The text is in a sans-serif font and appears to be white against a dark background. The logo is enclosed in a rounded rectangle, giving it a clean and modern look. The image quality is somewhat grainy, suggesting it may be a scan or a low-resolution photograph.
1
23 January 2007
FV
0F863.doc
revised
approved
signed
510(k) Summarv
K. 70246
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
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A. Name, Address, Phone and Fax number of the Applicant EndoTwinn B.V. Danzigerkade 17 1013 AP Amsterdam The Netherlands Telephone: +31 20 486 7571 Fax: +31 20 486 3280
FEB 1 6 2007 -
ങ്ക് Contact Person Frank Verhoeven
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C. Date Prepared 23 January 2007
D. Device Name
Trade Name: Down Pak Classification Name: Gutta Percha Prosthetic Device, Class 1 Regulation Number and Product Code: 872.3B50, EKM Classification Panel: Dental
E. Device Description
The device is a battery-operated dental instrument heater which is designed to provide continuous heat and/or vibration at the tip of a dental instrument. The low frequency vibration stimulates the transformation of gutta percha in a solid mass. The temperature is regulated by the type of tip attached to the handpiece and it automatically maintains a preset temperature for consistent results. The cordless handpiece is easily operated by a single button and can be recharged by placing the handpiece in a charger. The tips are autoclavable and the handpiece can be disinfect with 80% alcohol.
デ. Intended Use
The intended use of the dental instrument heater -- the Down Pak - is to provide continuous heat and/or vibration at the tip of a dental instrument. The Down Pak is designed for processing gutta percial (andring softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treament The device may only be operated by dentists and endodentists.
G. Substantial Equivalence
The dental instrument heater the Down Pak is a mod fied version of Endo Twinn and has the same technological characteristics. The modification is to change the plastic material of the user interface.
H. Device Testing Results
The Down Pak complies with the requirements of recognized consensus standards
- IEC 60601-1:1988 +A1. A2 -
- IEC 60601-1-2: 2001 -
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ISO 14971:2000 + A1
- ---ISO 10993-5:1999
- -ISO 10993-10:2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. F.M. Verhoeven Chief Operational Official EndoTwinn B.V. Danzigerkade 17, Amsterdam, Netherlands 1013 AP
FEB ] & 2007
Re: K070246
Trade/Device Name: Down Pak Regulation Number: 872.3850 Regulation Name: Gutta Percha Regulatory Class: I Product Code: EKM Dated: January 23, 2007 Received: January 25, 2007
Dear Mr. Verhoeven:
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. Verhoeven
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 (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.
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): K0610346
Device Name: Down Pak
Indications for Use:
The intended use of the dental instrument heater - The Down Pak - is to provide The intended use of the dontal instrument. The tip of a dental instrument. The Down Pak is continuous ficul and or vibration at a cutting softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment.
The device may only be operated by dentists and endodontists.
Prescription Use (Part 21 CFR 801 Subpart D)
ANI »/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Morley for 1958
K07024(
§ 872.3850 Gutta percha.
(a)
Identification. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.