(106 days)
Disposable Barrier Envelopes are intended to be used as a disposable barrier for Air Techniques Phosphor Storage Plates. This device is non-sterile and intended for single patient use only.
The ScanX barrier envelopes are made from one layer of clear blown polyethylene film and one layer of black blown polyethylene film heat sealed along three edges. An adhesive strip along the fourth edge is used for temporary barrier. Barrier Envelopes are used with Air Techniques' intraoral Phosphor Storage Plates. Barrier Envelopes are non-sterile, and disposable, single use only- discarded after each use.
The provided document is a 510(k) premarket notification for "ScanX Barrier Envelopes" and describes the acceptance criteria and study results demonstrating that the device meets these criteria.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Comparison Criteria | Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Testing: | |||
| In-Vitro Cytotoxicity | ANSI/AAMI/ISO 10993-5 | Score of Less Than 2 | Pass |
| Sensitization | ISO 10993-10 | Non-Sensitizer | Pass |
| Irritation | ISO 10993-10 | Non-Irritant | Pass |
| Biological Risk Assessment | ISO 10993-1 | Biological Safety | Pass |
| Performance and Mechanical Testing: | |||
| Synthetic Blood Penetration | ASTM F1670/F1670M | Protective Materials Resistance Against Liquid Penetration | Pass |
| Viral Penetration | ASTM F1671/F1671M | Protective Materials Resistance Against Blood Borne Pathogens | Pass |
| Tensile Strength | ASTM D882 | Tensile Properties of Material | Pass |
| Puncture Resistance | ASTM F1342 | Protective Materials Resistance to Puncture/Rupture | Pass |
| Tear Resistance | ASTM D1004 | Tear Resisting Ability | Pass |
| Image Quality | ISO 19232 | Determination of Image Quality of Radiographs ("Determination of Image Quality of Radiographs" is a broad descriptor for the standard, implying the device must maintain image quality when used. The specific quantitative acceptance criteria are not detailed in this section, but the "Pass" result indicates it met what was required.) | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists standards (e.g., ISO 10993, ASTM) that were followed for testing. These standards specify methodologies and may include sample size requirements within their procedures. However, the exact sample sizes used for each specific test in this study (e.g., "how many barrier envelopes were tested for tensile strength?") are not explicitly reported in this summary.
Regarding data provenance: The tests are material and mechanical property tests of a medical device (barrier envelopes), not clinical data involving patient information. Therefore, 'country of origin of the data' and 'retrospective or prospective' study design are not applicable in the typical sense for these types of non-clinical performance studies. The testing would have been conducted in a laboratory setting.
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)
This product (ScanX Barrier Envelopes) is a physical barrier device for dental phosphor storage plates. The "ground truth" for its performance is established through objective, standardized laboratory testing of its physical properties (e.g., tensile strength, resistance to penetration, biocompatibility) and its impact on image quality, as outlined by the listed ASTM and ISO standards. It does not involve human expert interpretation of medical images or diagnoses in the way an AI-driven diagnostic device would.
Therefore, this question (number of experts, qualifications, etc.) is not applicable to this type of device and study. The "ground truth" is derived from the results of the physical and chemical tests themselves, performed by qualified technicians in accredited labs according to the specified standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is primarily relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies between readers need to be resolved. Since this study involves objective laboratory measurements of physical properties, adjudication methods are not applicable. The results are quantitative measurements or pass/fail determinations based on predefined criteria within the respective standards.
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
No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is specifically designed to evaluate the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The ScanX Barrier Envelope is a physical accessory, not an AI diagnostic tool, so such a study would be irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also not applicable. The device is not an algorithm; it's a physical product. The "standalone performance" here refers to its ability to meet the specified physical and biological safety standards, which was indeed evaluated through the non-clinical tests listed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the ScanX Barrier Envelopes is based on objective, quantitative measurements and qualitative assessments derived from adherence to recognized national and international standards (ASTM, ISO) for material properties, barrier effectiveness, biocompatibility, and image quality. This is not clinical ground truth (like pathology or outcomes data) but rather engineering and safety ground truth.
8. The sample size for the training set
The concept of "training set" is specific to machine learning and AI algorithms. Since this device is not an AI algorithm, there was no training set in that context. The development and testing of the barrier envelopes would involve material science, engineering, and manufacturing processes, not AI model training.
9. How the ground truth for the training set was established
As there was no AI model training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2019
Air Techniques Inc. Samir Ghevariya Regulatory Affairs Specialist 1295 Walt Whitman Road Melville, New York 11747
Re: K190949
Trade/Device Name: ScanX Barrier Envelopes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape And Drape Accessories Regulatory Class: Class II Product Code: PEM Dated: June 19, 2019 Received: June 20, 2019
Dear Samir Ghevariya:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K190949
Device Name ScanX Barrier Envelopes
Indications for Use (Describe)
Disposable Barrier Envelopes are intended to be used as a disposable barrier for Air Techniques Phosphor Storage Plates. This device is non-sterile and intended for single patient use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
| × | Over-The-Counter Use (21 CFR 801 Subpart C)
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| ScanX Barrier Envelopes Model Numbers (Attachment to the Indications for UseStatement- Form FDA 3881) | ||
|---|---|---|
| Model (Part)Number: | Device Description: | Device Size (In Inches): |
| 73248-0 | ScanX Barrier Envelope; 100 Pcs/Box,Size #0 | 1.46 In x 0.96 In |
| 73248-1 | ScanX Barrier Envelope; 100 Pcs/Box,Size #1 | 1.68 In x 1.04 In |
| 73248-2 | ScanX Barrier Envelope; 300 Pcs/Box,Size #2 | 1.73 In x 1.32 In |
| 73248-2k | ScanX Barrier Envelope; 1000 Pcs/Box,Size #2 | 1.73 In x 1.32 In |
| 73248-3 | ScanX Barrier Envelope; 100 Pcs/Box,Size #3 | 2.23 In x 1.16 In |
| 73248-4 | ScanX Barrier Envelope; 100 Pcs/Box,Size #4 | 3.20 In x 2.35 In |
| G8511-0 | ScanX Side Loading Barrier Envelope;100 Pcs/Box, Size #0 | 1.52 In x 0.98 In |
| G8511-1 | ScanX Side Loading Barrier Envelope;100 Pcs/Box, Size #1 | 1.67 In x 1.02 In |
| G8511-2 | ScanX Side Loading Barrier Envelope;300 Pcs/Box, Size #2 | 1.75 In x 1.34 In |
| G8511-2k | ScanX Side Loading Barrier Envelope;1000 Pcs/Box, Size #2 | 1.75 In x 1.34 In |
| G8511-3 | ScanX Side Loading Barrier Envelope;100 Pcs/Box, Size #3 | 2.22 In x 1.14 In |
| G8511-4 | ScanX Side Loading Barrier Envelope; 50Pcs/Box, Size #4 | 3.09 In x 2.40 In |
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Image /page/4/Picture/0 description: The image shows the logo for "Air Techniques". The logo is in blue and features the words "Air Techniques" in a bold, sans-serif font. Above the word "Techniques" is the phrase "equipped for life®" in a smaller font. The "A" and "T" in "Air Techniques" are stylized and connected.
510(k) Summary, Air Techniques Inc.
ScanX Barrier Envelopes. K190949
The summary of 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92
1. Date Summary Prepared:
July 22, 2019
2. Submitter's Identification:
Air Techniques Inc. 1295 Walt Whitman Road Melville, NY 11747 USA Tel: +1-516-433-7676 Fax: +1-516-740-4622 Website: www.airtechniques.com
Contact Information:
Samir Ghevariya Regulatory Affairs Specialist Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 USA Tel: +1-516-214-5514 Fax: +1-516-740-4622 Email: Samir.Ghevariya@airtechniques.com
3. Device Name:
| Trade /Proprietary Name: ScanX Barrier Envelopes | |
|---|---|
| Device: | Dental barriers and sleeves |
| Regulation Number: | 21 CFR 878.4370 |
| Regulation description: | Surgical drape and drape accessories |
| Regulatory Class: | II |
| Product Code: | PEM |
| Review Panel: | Dental |
4. Legally Marketed Predicate Device Information:
510(k) Number: K163447
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Image /page/5/Picture/0 description: The image shows the logo for Air Techniques. The logo is blue and white, with the words "AIR TECHNIQUES" in large, bold letters. Above the word "TECHNIQUES" is the phrase "equipped for life" in smaller letters. The logo is simple and modern, and it conveys a sense of quality and reliability.
| Manufacturer: | Premium Plus International Limited. |
|---|---|
| Trade /Proprietary Name: | Premium Plus Disposable Barrier Sleeve |
| Device: | Dental barriers and sleeves |
| Regulation Number: | 21 CFR 878.4370 |
| Regulation description: | Surgical drape and drape accessories |
| Regulatory Class: | II |
| Product Code: | PEM |
| Review Panel: | Dental |
5. Device Description:
The ScanX barrier envelopes are made from one layer of clear blown polyethylene film and one layer of black blown polyethylene film heat sealed along three edges. An adhesive strip along the fourth edge is used for temporary barrier. Barrier Envelopes are used with Air Techniques' intraoral Phosphor Storage Plates. Barrier Envelopes are non-sterile, and disposable, single use only- discarded after each use.
6. Intended use/Indications for use:
Disposable Barrier Envelopes are intended to be used as a disposable barrier for Air Techniques Phosphor Storage Plates. This device is non-sterile and intended for single patient use only.
7. Device Models:
| Model (Part)Number: | Device Description: | Device Size (In Inches): |
|---|---|---|
| 73248-0 | ScanX Barrier Envelope; 100 Pcs/Box, Size #0 | 1.46 In x 0.96 In |
| 73248-1 | ScanX Barrier Envelope; 100 Pcs/Box, Size #1 | 1.68 In x 1.04 In |
| 73248-2 | ScanX Barrier Envelope; 300 Pcs/Box, Size #2 | 1.73 In x 1.32 In |
| 73248-2k | ScanX Barrier Envelope; 1000 Pcs/Box, Size #2 | 1.73 In x 1.32 In |
| 73248-3 | ScanX Barrier Envelope; 100 Pcs/Box, Size #3 | 2.23 In x 1.16 In |
| 73248-4 | ScanX Barrier Envelope; 100 Pcs/Box, Size #4 | 3.20 In x 2.35 In |
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Image /page/6/Picture/0 description: The image shows the logo for Air Techniques. The logo is blue and white. The words "AIR TECHNIQUES" are stacked on top of each other, with the word "AIR" on top and the word "TECHNIQUES" on the bottom. To the right of the words is the phrase "equipped for life®".
| G8511-0 | ScanX Side Loading BarrierEnvelope; 100 Pcs/Box, Size #0 | 1.52 In x 0.98 In |
|---|---|---|
| G8511-1 | ScanX Side Loading BarrierEnvelope; 100 Pcs/Box, Size #1 | 1.67 In x 1.02 In |
| G8511-2 | ScanX Side Loading BarrierEnvelope; 300 Pcs/Box, Size #2 | 1.75 In x 1.34 In |
| G8511-2k | ScanX Side Loading BarrierEnvelope; 1000 Pcs/Box, Size#2 | 1.75 In x 1.34 In |
| G8511-3 | ScanX Side Loading BarrierEnvelope; 100 Pcs/Box, Size #3 | 2.22 In x 1.14 In |
| G8511-4 | ScanX Side Loading BarrierEnvelope; 50 Pcs/Box, Size #4 | 3.09 In x 2.40 In |
8. Technological Characteristics:
Shown below is the technological characteristics comparison of the Air Techniques ScanX Barrier Envelopes with the Disposable Barrier Sleeves (predicate device).
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Image /page/7/Picture/0 description: The image is a logo for Air Techniques. The logo is blue and features the words "AIR TECHNIQUES" in a bold, sans-serif font. Above the word "TECHNIQUES" is the phrase "equipped for life®" in a smaller font. The logo is simple and modern.
Technological Characteristic Comparison Table
| ComparisonCriteria | Predicate Device:Premium PlusDisposable BarrierSleeves (K163447) | New Device: ScanXBarrier Envelopes(K190949) | Comparison | |
|---|---|---|---|---|
| ProductPictures | Image: Premium Plus Disposable Barrier Sleeves (K163447) | Image: ScanX Barrier Envelopes (K190949) | Similar | |
| Intended Use | Premium PlusDisposable BarrierSleeves are intended tobe used as a disposablebarrier for dentalinstruments andequipment. This deviceis non-sterile andintended for singlepatient use only. | Disposable BarrierEnvelopes are intendedto be used as adisposable barrier forAir TechniquesPhosphor StoragePlates. This device isnon-sterile andintended for singlepatient use only. | Same | |
| ClassificationProduct Code | PEM | PEM | Same | |
| Material | Polyethylene film | Polyethylene film | Similar | |
| MaterialComposition | Low densitypolyethylene and linearlow density polyethylenefilm | Low densitypolyethylene | Similar | |
| Biocompatibility | Non-cytotoxicNon-sensitizingNon-irritating | Non-cytotoxicNon-sensitizingNon-irritating | Similar | |
| Film Thickness | 0.03 mm | 0.025 mm0.027 mm0.030 mm | ||
| MechanicalProperties | Tensile strength- testedin compliance withASTM D882 | Tensile strength- testedin compliance withASTM D882 | Similar | |
| Puncture resistance-tested in compliancewith ASTM F1342 | Puncture resistance-tested in compliancewith ASTM F1342 | |||
| Tear resistance- testedin compliance withASTM D1004 | Tear resistance- testedin compliance withASTM D1004 | |||
| Sterility | Non-sterile | Non-sterile | Same | |
| Single Use | Single use device | Single use device | Same | |
| PerformanceProperties | Synthetic BloodPenetration- PassViral Penetration- Pass | Synthetic BloodPenetration- PassViral Penetration- Pass | Same | |
| Dimensions | Determined by the sizeand shape of PhosphorPlates they cover | Difference in dimensionis due to the size ofPhosphor StoragePlates they cover | Similar | |
| FDARecognizedStandards | ISO 10993-5ISO 10993-10ASTM F1670ASTM F1671 | ANSI/AAMI/ISO 10993-5:2009/(R2014)ISO 10993-10 | Similar |
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Image /page/8/Picture/0 description: The image is a logo for "AIR TECHNIQUES equipped for life". The words "AIR" and "TECHNIQUES" are in a bold, blue font. The word "AIR" is stacked on top of the word "TECHNIQUES", and the letters "AI" are inside of a blue square. The words "equipped for life" are in a smaller, lighter blue font and are located to the right of the word "AIR".
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Image /page/9/Picture/0 description: The image is a logo for "AIR TECHNIQUES" with the tagline "equipped for life®". The words "AIR" are stacked on top of the word "TECHNIQUES". The logo is in blue and white.
| ASTM D882ASTM F1342ASTM D1004 | ANSI/AAMI/ISO 10993-12:2012ISO 10993-1:2018ANSI/AAMI PB70:2012ISO 14971:2007ASTM F1670ASTM F1671ASTM D882ASTM F1342ASTM D1004ISO 19232 |
|---|---|
| --------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
-
- Summary of Non-Clinical Data and Performance Testing: Shown below is a listing of the performance testing performed to demonstrate The functionalitv of the ScanX Barrier Envelopes.
| ComparisonCriteria | Standards | AcceptanceCriteria | Results |
|---|---|---|---|
| Biocompatibility Testing: | |||
| In-Vitro Cytotoxicity | ANSI/AAMI/ISO10993-5 | Score of Less Than 2 | Pass |
| Sensitization | ISO 10993-10 | Non-Sensitizer | Pass |
| Irritation | ISO 10993-10 | Non-Irritant | Pass |
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Image /page/10/Picture/0 description: The image shows the logo for Air Techniques. The logo is blue and white, with the words "AIR TECHNIQUES" in large, bold letters. Above the word "TECHNIQUES" is the phrase "equipped for life®" in a smaller font. The logo is simple and modern, and it conveys a sense of quality and reliability.
| Biological Risk | ISO 10993-1 | Biological Safety | Pass |
|---|---|---|---|
| Assessment | |||
| Performance and Mechanical Testing: | |||
| Synthetic BloodPenetration | ASTMF1670/F1670M | Protective MaterialsResistance AgainstLiquid Penetration | Pass |
| Viral Penetration | ASTMF1671/F1671M | Protective MaterialsResistance AgainstBlood BornePathogens | Pass |
| Tensile Strength | ASTM D882 | Tensile Propertiesof Material | Pass |
| PunctureResistance | ASTM F1342 | Protective MaterialsResistance toPuncture/Rupture | Pass |
| Tear Resistance | ASTM D1004 | Tear ResistingAbility | Pass |
| Image Quality | ISO 19232 | Determination ofImage Quality ofRadiographs | Pass |
The results from the non-clinical performance test demonstrated that the subject device met the acceptance criteria for each standard test performed.
10. Clinical Data:
NA
12. Conclusion:
The conclusions drawn from the nonclinical tests that demonstrate that the ScanX Barrier Envelopes is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K163447).
§ 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.