(65 days)
Not Found
None
No
The 510(k) summary describes a simple disposable barrier sleeve and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a barrier sleeve for dental instruments and equipment, not something that treats or diagnoses a medical condition.
No
Explanation: The device is a disposable barrier sleeve for dental instruments and equipment. Its intended use is to act as a barrier, not to diagnose medical conditions or diseases.
No
The device is described as "Disposable Barrier Sleeves," which are physical products intended for use as barriers. This description clearly indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "disposable barrier for dental instruments and equipment." This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status, which are hallmarks of IVDs.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No Mention of Biological Samples: The text focuses on dental instruments and equipment, not biological samples.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Disposable Barrier Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
Product codes
PEM
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.
May 11, 2022
Premium Plus (Dongguan) Limited Jessica Mao Regulatory Affairs No.1 Industrial Area, Tutang, Changping Dongguan, Guangdong 523581 CHINA
Re: K220662
Trade/Device Name: Disposable Barrier Sleeves Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: March 2, 2022 Received: March 7, 2022
Dear Jessica Mao:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220662
Device Name Disposable Barrier Sleeves
Indications for Use (Describe)
Disposable Barrier Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
| Model# | Description | Designed for |
|---|---|---|
| 100B | Syringe/HVE Sleeves Blue | 3-way syringes, saliva ejectors and HVE valve |
| 100C | Syringe/HVE Sleeves Clear | 3-way syringes, saliva ejectors and HVE valve |
| 101 | Tray Sleeves Standard 'B' | Instrument trays |
| 102 | Tray Sleeves Mini 'F' | Instrument trays |
| 103 | Pen Shaped Instrument Sleeves | Most handpieces, jet polishers and ultrasonic scalers |
| 104L | Low Speed/ Universal Handpiece Sleeves, Large | Most handpieces, jet polishers and ultrasonic scalers |
| 104S | Low Speed/ Universal Handpiece Sleeves, Small | Most handpieces, jet polishers and ultrasonic scalers |
| 105T | Pistol Type Curing Light Sleeves | Curing light, pistol type |
| 106 | T-Style Light Handle Sleeves, U-shape | Most T-style dental chair light handles |
| 107 | Impression Gun Sleeves | Impression guns |
| 108 | X-Ray Head / Keyboard Sleeves | X-ray head/keyboard |
| 109 | X-Ray Head Sleeves | X-ray head |
| 111 | Full Chair Sleeves | Dental chairs |
| 112 | Half Chair Sleeves | Dental chairs/stools |
| 113 | Headrest Sleeves Small | Dental chair headrest |
| 114 | Headrest Sleeves Large | Dental chair headrest |
| 118 | Straight Tubing Sleeves | Dental chair tubing |
| 119 | Coiled Tubing Sleeves | Dental chair tubing |
| 123L | Pen Type Curing Light Sleeves, Large | Curing lights, pen type |
| 123S | Pen Type Curing Light Sleeves, Small | Curing lights, pen type |
| 123SS | Pen Type Curing Light Sleeves, X-Small | Curing lights, pen type |
| 123XL | Pen Type Curing Light Sleeves, X-Large | Curing lights, pen type |
| 125 | Intraoral Camera Sleeves | Intraoral Cameras |
| 125SS | Intraoral Camera/RA Curing Light Sleeves | Intraoral Cameras/curing lights |
| 128 | Light Guide Sleeves, Small | Curing light guides |
| 129 | Light Guide Sleeves, Large | Curing light guides |
| 133 | PC Mouse Sleeves | PC mouses |
| 135L | HVE Tube Sleeves, Large | HVE suction tubes |
| 135S | HVE Tube Sleeves, Small | HVE suction tubes |
| 136 T | Light Handle Sleeves, Rectangular | T-style dental chair light handles |
| 138 | Flowable Composite Syringe Sleeves | Composite syringes |
| 140L | X-Ray Sensor Sleeves, Large | X-ray sensors |
| 140M | X-Ray Sensor Sleeves, Medium | X-ray sensors |
| 140S | X-Ray Sensor Sleeves | X-ray sensors |
| 140XS | X-Ray Sensor/Mouth Mirror Sleeves | X-ray sensors/mouth mirrors |
| 145 | Bite Block Sleeves | Bite Block |
| 158 | Keyboard Sleeves | Keyboards |
| 183-1 | Two Step X-Ray Sensor Sleeves, Size 1 | X-ray sensors |
| 183-2 | Two Step X-Ray Sensor Sleeves, Size 2 | X-ray sensors |
| 190 | ISO Tray Sleeves | Instrument Trays |
| 228 | Intraoral Camera Sleeves/ RA Curing Light Sleeves Mini Short | Intraoral Camera, RA curing lights |
| 8008-B | Barrier Film, Clear | Surface area that might be touched during procedure |
| 8008-C | Barrier Film, Blue | Surface area that might be touched during procedure |
| 188-0 PSP | X-Ray Barrier Envelopes, No. 0 | Phosphor Plates |
| 188-1 PSP | X-Ray Barrier Envelopes, No. 1 | Phosphor Plates |
| 188-2 PSP | X-Ray Barrier Envelopes, No. 2 | Phosphor Plates |
| 188-3 PSP | X-Ray Barrier Envelopes, No. 3 | Phosphor Plates |
| 188-4 PSP | X-Ray Barrier Envelopes, No. 4 | Phosphor Plates |
| 189-0 PSP | X-Ray Barrier Envelopes, No. 0 | Phosphor Plates |
| 189-1 PSP | X-Ray Barrier Envelopes, No. 1 | Phosphor Plates |
| 189-2 PSP | X-Ray Barrier Envelopes, No. 2 | Phosphor Plates |
| 198-0 PSP | X-Ray Barrier Envelopes, No. 0 | Phosphor Plates |
| 198-1 PSP | X-Ray Barrier Envelopes, No. 1 | Phosphor Plates |
| 198-2 PSP | X-Ray Barrier Envelopes, No. 2 | Phosphor Plates |
| 199-0 PSP | X-Ray Barrier Envelopes, No. 0 | Phosphor Plates |
| 199-1 PSP | X-Ray Barrier Envelopes, No. 1 | Phosphor Plates |
| 199-2 PSP | X-Ray Barrier Envelopes, No. 2 | Phosphor Plates |
| 8008-B | Barrier Film, Clear | Surface area that might be touched during procedure |
| 8008-C | Barrier Film, Blue | Surface area that might be touched during procedure |
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Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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