(106 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of the envelopes, with no mention of AI or ML.
No
The device is a disposable barrier envelope for phosphor storage plates, not an active therapeutic device. Its purpose is to provide a barrier and is discarded after single use.
No
The device is a disposable barrier envelope for phosphor storage plates, designed to protect the plates during use, not to diagnose medical conditions. Its performance testing focuses on barrier integrity and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is a physical product made of polyethylene film and used as a barrier envelope, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be a "disposable barrier for Air Techniques Phosphor Storage Plates." This describes a physical barrier used during the process of capturing dental images, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the materials and construction of a protective envelope. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The device is clearly described as a barrier for imaging plates, which falls under the category of accessories used in medical imaging, not in vitro diagnostics.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
PEM
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.
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)
Summary of Non-Clinical Data and Performance Testing:
The following performance testing was performed to demonstrate the functionality of the ScanX Barrier Envelopes:
- 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 - Pass
The results from the non-clinical performance test demonstrated that the subject device met the acceptance criteria for each standard test performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). 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
1
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
2
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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3
| ScanX Barrier Envelopes Model Numbers (Attachment to the Indications for Use
| Statement- 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; 50 | |
| Pcs/Box, Size #4 | 3.09 In x 2.40 In |
4
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
5
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 |
6
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 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; 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).
7
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
| Comparison
Criteria | Predicate Device:
Premium Plus
Disposable Barrier
Sleeves (K163447) | New Device: ScanX
Barrier Envelopes
(K190949) | Comparison | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------|
| Product
Pictures | Image: Premium Plus Disposable Barrier Sleeves (K163447) | Image: ScanX Barrier Envelopes (K190949) | Similar | |
| Intended Use | Premium Plus
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. | 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. | Same | |
| Classification
Product Code | PEM | PEM | Same | |
| Material | Polyethylene film | Polyethylene film | Similar | |
| Material
Composition | Low density
polyethylene and linear
low density polyethylene
film | Low density
polyethylene | Similar | |
| | Biocompatibility | Non-cytotoxic
Non-sensitizing
Non-irritating | Non-cytotoxic
Non-sensitizing
Non-irritating | Similar |
| | | Film Thickness | 0.03 mm | 0.025 mm
0.027 mm
0.030 mm |
| Mechanical
Properties | | Tensile strength- tested
in compliance with
ASTM D882 | Tensile strength- tested
in compliance with
ASTM D882 | Similar |
| | | Puncture resistance-
tested in compliance
with ASTM F1342 | Puncture resistance-
tested in compliance
with ASTM F1342 | |
| | | Tear resistance- tested
in compliance with
ASTM D1004 | Tear resistance- tested
in compliance with
ASTM D1004 | |
| | Sterility | Non-sterile | Non-sterile | Same |
| Single Use | Single use device | Single use device | Same | |
| Performance
Properties | Synthetic Blood
Penetration- Pass
Viral Penetration- Pass | Synthetic Blood
Penetration- Pass
Viral Penetration- Pass | Same | |
| Dimensions | Determined by the size
and shape of Phosphor
Plates they cover | Difference in dimension
is due to the size of
Phosphor Storage
Plates they cover | Similar | |
| | FDA
Recognized
Standards | ISO 10993-5
ISO 10993-10
ASTM F1670
ASTM F1671 | ANSI/AAMI/ISO 10993-
5:2009/(R2014)
ISO 10993-10 | Similar |
8
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".
9
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 D882
ASTM F1342
ASTM D1004 | ANSI/AAMI/ISO 10993-
12:2012
ISO 10993-1:2018
ANSI/AAMI PB70:2012
ISO 14971:2007
ASTM F1670
ASTM F1671
ASTM D882
ASTM F1342
ASTM D1004
ISO 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.
| Comparison
Criteria | Standards | Acceptance
Criteria | Results |
|---------------------------|--------------------------|------------------------|---------|
| 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 |
10
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 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 | 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).