(52 days)
Not Found
No
The device is a simple disposable sheath for an intraoral camera, with no mention of any image processing, AI, or ML capabilities.
No.
The device is intended to prevent contamination of a camera handpiece, not to diagnose, treat, or prevent disease.
No
Explanation: The device is described as an intraoral camera sheath, the purpose of which is to prevent contamination of the camera handpiece. Its function is protective and does not involve analyzing biological samples or signals to determine a medical condition, disease, or risk, which would be characteristic of a diagnostic device. The predicate device is also a thermometer sheath, further supporting its non-diagnostic nature.
No
The device description clearly states it is a "single-use device" and a "sheath," which are physical, hardware components. There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the AcuCam Intraoral Camera Sheath is to prevent contamination of the camera handpiece. It is a barrier device used during a medical procedure (intraoral imaging).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Function: The sheath itself does not perform any diagnostic test or provide any information about a patient's health condition. It is a protective accessory for a medical device.
- Predicate Device: The predicate device listed (Sanitherm Oral Disposable Thermometer Sheath) is also a barrier device, not an IVD.
Therefore, based on the provided information, the AcuCam Intraoral Camera Sheath is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended 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.
Product codes
KKX
Device Description
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.
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
Not Found
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
Biocompatibility testing was conducted in accordance with ISO 10993-5.
Key Metrics
Not Found
Predicate Device(s)
Sanitherm Oral Disposable Thermometer Sheath, 510(k) K983406
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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 Division
901 West Oakton Street
Des Plaines, IL 60018-1884 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | William T. Cousins
Area Manger Quality Assurance & Regulatory Affairs
phone: (847) 640-4924
fax: (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 intended
for use with intraoral camera systems. The intraoral camera handpiece
is 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.
3
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.
4
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. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
..............................................................................................................................................................................
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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