(52 days)
The AcuCam® Intraoral Camera Sheath is a single-use device intended for use with the various intraoral camera systems to prevent contamination of the camera handpiece with saliva and other bodily fluids.
The AcuCam Intraoral Camera Sheath is a single-use device intended for use with intraoral camera systems. The intraoral camera handpiece is inserted into the sheath prior to use.
The provided text is a 510(k) summary for the AcuCam® Intraoral Camera Sheath. This document describes a medical device and its substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria based on performance data.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies cannot be extracted from this document, as it focuses on regulatory submission for a simple medical device, not a performance-based study as typically seen with AI/ML devices or complex diagnostic tools.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document does not describe acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or report device performance against such criteria. The device is a "surgical drape and drape accessory" (specifically, an intraoral camera sheath) whose primary function is to prevent contamination. The rationale for substantial equivalence focuses on material, manufacturing, and dimensions, not diagnostic performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. There is no mention of a "test set" or data provenance as would be relevant for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a test set is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This device is a physical sheath, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as would be relevant for an algorithm.
9. How the ground truth for the training set was established
Not applicable.
Summary of Relevant Information from the Document:
While most of your questions are not applicable to this type of regulatory submission, here's what can be extracted that is tangentially related:
- Device Purpose and Rationale for Equivalence: The AcuCam® Intraoral Camera Sheath is a single-use device intended to prevent contamination of intraoral camera systems with saliva and other bodily fluids. Its safety and effectiveness are established by demonstrating substantial equivalence to a predicate device (Sanitherm Oral Disposable Thermometer Sheath, K983406).
- Key Equivalence Factors:
- Identical Indications for Use: Both devices are used to prevent contamination.
- Identical Materials: The AcuCam sheath is manufactured with the same materials as the predicate.
- Identical Manufacturing Process: The manufacturing process is the same.
- Identical Inspection and Test Procedures: The procedures used for quality control are the same.
- Difference: The only noted difference between the AcuCam sheath and the predicate device is its size, to accommodate intraoral camera handpieces.
- Biocompatibility Testing: Biocompatibility of the materials used in the AcuCam sheath was demonstrated in accordance with ISO 10993-5. This is a common "acceptance criterion" for materials in contact with the body, ensuring the material itself does not cause harm. However, no specific test results (e.g., cytotoxicity scores) are provided, only that it "was conducted in accordance with" the standard.
- Conclusion of Substantial Equivalence: The FDA's letter (K994211) indicates that the device has been found substantially equivalent to the legally marketed predicate. This substantial equivalence determination serves as the "proof" that the device meets regulatory requirements for marketing.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines above them.
Public Health Service
OCT 2 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William T. Cousins Area Manager Quality Assurance & Regulatory Affairs Dentsply International 901 West Oakton Street Des Plaines, Illinois 60018-1884
Re: K994211
Trade/Device Name: AcuCam® Intraoral Camera Sheath Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: December 1, 1999 Received: December 14, 1999
Dear Mr. Cousins:
This letter corrects our substantially equivalent letter of February 14, 2000 regarding the product code.
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 (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 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. Cousins
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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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/dsma/dsmamain.html
Sincerely yours,
Shiu-Lin, Ph.D.
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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FEB 1 4 2000
Attachment 11: 510(k) Summary of Safety and Effectiveness AcuCam® Intraoral Camera Sheath
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
| Submitter: | DENTSPLY International, Inc.Gendex Dental X-ray Division901 West Oakton StreetDes Plaines, IL 60018-1884 |
|---|---|
| Contact Person: | William T. CousinsArea Manger Quality Assurance & Regulatory Affairsphone: (847) 640-4924fax: (847) 640-4970 |
| Date Prepared: | December 1, 1999 |
| Device Name: | AcuCam® Intraoral Camera Sheath |
| Common Name: | AcuCam Sheath |
| Classification Name: | Dental Operative Device, EIA, 872.6640 |
| Predicate Device: | Sanitherm Oral Disposable Thermometer Sheath, 510(k) K983406 |
| Product Description: | The AcuCam Intraoral Camera Sheath is a single-use device intendedfor use with intraoral camera systems. The intraoral camera handpieceis inserted into the sheath prior to use. |
- Indications for Use: The AcuCam Intraoral Camera Sheath is a single-use device intended for use with intraoral camera systems to prevent contamination of the camera handpiece with saliva and other bodily fluids.
Rationale for Substantial Equivalence
The AcuCam Intraoral Camera Sheath shares the same indications for use as the predicate device. It is manufactured with identical materials, manufacturing process, and inspection and test procedures. The difference between the AcuCam Intraoral Camera Sheath and the predicate device is the size. Biocompatibility of materials has been demonstrated.
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Safety and Effectiveness Information:
There are no differences between the design or manufacture of the AcuCam Intraoral Camera Sheath and the predicate device that could affect effectiveness relative to the intended use. Biocompatibility testing was conducted in accordance with ISO 10993-5.
Conclusion:
The AcuCam Intraoral Camera Sheath was found to be substantially equivalent to the predicate device. The AcuCam Intraoral Camera Sheath is substantially equivalent to the predicate device except that the AcuCam Intraoral Camera Sheath is larger in size.
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Section 3: Intended Use
| 510(k) Number (if known): | K994424 K994211 |
|---|---|
| Device Name: | DENTSPLY International, Inc. AcuCam® Intraoral Camera Sheath |
| Indications for Use: | The AcuCam® Intraoral Camera Sheath is a single-use device intended for use with the various intraoral camera systems to prevent contamination of the camera handpiece with saliva and other bodily fluids. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
(Optional Format 1-2-96)
000009
Olin S. Lin
(Division Sign-Off) Division of Dental, Infection Cor and General Hospital 510(k) Number
3-1
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§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.