(67 days)
GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.
GuttaFlow is a Class II, permanent root canal filling material. GuttaFlow is silicone based (Polydimethysiloxane) and consists additionally of Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid.
Here's a breakdown of the acceptance criteria and study information for GuttaFlow based on the provided FDA 510(k) summary:
This device is cleared through the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria and performance measures in the same way a PMA device would. Therefore, much of the requested information regarding detailed study design, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment as it relates to a "device performance study" might not be applicable in the traditional sense for this type of submission.
Instead, the "study" demonstrating adherence to acceptance criteria is primarily a comparison against a legally marketed predicate device, focusing on technical characteristics and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on Substantial Equivalence to Predicate) | Reported GuttaFlow Performance |
|---|---|
| Material Composition | Silicone based (Polydimethysiloxane) with Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid. (Similar to predicate, with specific additions/differences noted). |
| Biocompatibility | Very similar to predicate device RoekoSeal. (Implied to meet the same biocompatibility standards as the predicate, which is a Class II device). |
| Dimension Stability | Very similar to predicate device RoekoSeal. |
| Flow | Very similar to predicate device RoekoSeal. |
| Film Thickness | Very similar to predicate device RoekoSeal. |
| Solubility | Very similar to predicate device RoekoSeal. |
| Resorbability | Not resorbable. (Consistent with predicate). |
| Intended Use | Permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal. (Matches the predicate's intended use for root canal filling materials, classified under 21 CFR 872.3820). |
| Curing Time | Differences in curing time compared to predicate. (This is noted as a difference, implying it's acceptable as long as the change does not raise new questions of safety or effectiveness and the device still functions as intended). |
| Addition of Gutta Percha and Zinc Oxide | Added to the formulation compared to the predicate. (This difference is acknowledged and accepted, as it does not change the fundamental safety or effectiveness profile as a root canal filling material, but rather provides features or properties potentially perceived as upgrades or differentiators). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided summary. For a 510(k), the "test set" primarily refers to samples used for in vitro bench testing to demonstrate technical equivalence, rather than a clinical trial with a patient test set. No clinical studies are referenced.
- Data Provenance: Not explicitly stated. Given it's a 510(k) submission primarily comparing technical characteristics to a predicate, the data would likely be from internal laboratory testing conducted by the manufacturer (Coltène/Whaledent GmbH & Co. KG). It would be retrospective in the sense that it's comparing against existing data for the predicate and generating new data for GuttaFlow, but not a prospective clinical trial. The country of origin for the data would likely be related to the manufacturer's location, which is Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable/not provided in this 510(k) summary. For a 510(k) based on substantial equivalence to a predicate, the "ground truth" for device performance is generally established through recognized standards, predicate device performance data, and scientific principles, not through expert consensus on a clinical test set.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.
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. This device (GuttaFlow) is a dental material, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/not provided. As mentioned above, this is a dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" in this context is based on technical specifications, established material properties, and the performance profile of the legally marketed predicate device (RoekoSeal). Equivalence is demonstrated by showing that GuttaFlow's technical characteristics, biological properties, and intended use are "substantially equivalent" to those of the predicate device, which itself has an established safe and effective use history. This also includes adherence to relevant dental material standards (though not explicitly listed, they would be implicit in the assessment of such properties).
8. The Sample Size for the Training Set
- This information is not applicable/not provided. There is no mention of a "training set" in the context of machine learning or AI for this dental material device.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable/not provided. As there is no training set mentioned, there's no ground truth establishment for it.
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OV = 3 2003
coltène
whaledent
510(k) Submission GuttaFlow 510 (K) STATEMENT ( Summary ) (As required by 21 CFR 807.93)
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21CFR § 807.92.
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- GuttaFlow is a Class II, permanent root canal filling material.
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- GuttaFlow is substantially equivalent to RoekoSeal-K973539 which is also manufactured and distributed by Coltène/Whaledent.GmbH + Co. KG.
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- GuttaFlow is silicone based (Polydimethysiloxane) and consists additionally of Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid.
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- The technical characteristics of Gutta Flow are similar to those of the predicate device RoekoSeal which is also silicone based. Dimension stability, flow, film thickness, biocompatibility and solubility are very similar for both materials. Differences are primarily in the GuttaFlow curing time and the addition of Gutta Percha and Zinc oxide.
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- GuttaFlow and RoekoSeal are not resorbable.
(Signature)
H. Vogelstein
N/A
Date 20 August 2013
Official Correspondent &
US @gent
(Premarket Notification [510(k)]Number)
380-12
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes above its head, symbolizing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
NOV - 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Coltene/Whaledent GmbH & Company KG C/O Mr. Henry J. Vogelstein Consultant Coltene/Whaledent, Incorporated 235 Ascot Parkway Cuyahoga Falls, Ohio 44223
Re: K032662
Trade/Device Name: GuttaFlow Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Codes: KIF and EKM Dated: August 22, 2003 Received: August 28, 2003
Dear Mr. Vogelstein:
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. Henry J. Vogelstein
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 (OS) 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. 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) you may obtain. 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 vours.
Patricia Cucenttfor
Chiu S. Lin. PhD 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
Page 1 of
14032662 510(k) Number (if known):
Device Name: GuttaFlow
Indications for Use:
GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use V (Per 21 CFR 801.109)
OR Over-the-Counter Use
Suser Runo
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K033662
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.