(350 days)
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are related to material properties and biocompatibility, not algorithmic performance.
Yes
Explanation: The device is described as a "treatment option for Class III malocclusion," indicating its purpose is to treat a medical condition.
No
The device is described as a "treatment option" for Class III malocclusion and functions as an extraoral appliance that provides anchorage support for elastics in orthodontic treatment, rather than identifying or analyzing a medical condition.
No
The device description clearly outlines physical components made of stainless steel and EVA plastic foam, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Use as a treatment option for Class III malocclusion." This describes a therapeutic intervention applied directly to the patient's face to correct a physical condition.
- Device Description: The description details a physical, extraoral device used for mechanical force application. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample collection, or any other components or processes typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. This device does not fit that description.
N/A
Intended Use / Indications for Use
Use as a treatment option for Class III malocclusion.
Product codes
DZB
Device Description
The Reverse Pull Adjustable Facemask is an extra oral device placed on the face of a patient. The subject device is provided assembled; packaged in a plastic heat sealed bag placed in a nylon pouch, to safeguard the integrity of the packaging. The device is provided non(sterile. No prior skin preparation is required to use the device. The skin contacting surfaces may require light cleaning with water between uses, depending on the patient's personal hygiene.
The subject device consists of a vertical main frame, made of 304(grade stainless steel, having adjustable supports for the patient's forehead and chin. The two supports are lined with Ethylene( Vinyl Acetate (EVA) plastic foam for patient comfort. Moreover, the forehead support has two vents to allow airflow to skin in contact with the support. Two additional EVA pads for forehead and chin supports are included for patient comfort and hygiene.
An elastic capstan crossbar made of 304 grade stainless steel, with an allen screw is present on the vertical main frame between the forehead and chin support. The crossbar is utilized by the Orthodontic practitioner as a means of anchorage support for attaching elastics to intraoral appliances. Elastics or the intraoral appliances are not provided with this device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face of patient.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthodontic practitioner
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)
Nonclinical Tests Discussion: Performance tests in accordance to ISO 6892(1:2016 for tensile testing of metallic materials at room temperature was conducted on the final finished device configuration as well as the predicate device to determine the equivalence.
Clinical Tests Discussion: No clinical field trials have been conducted with Reverse Pull Adjustable Facemask.
Key results: The subject device has a similar tensile strength as the predicate and is therefore substantially similar to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5500 Extraoral orthodontic headgear.
(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem consisting of three stylized human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
August 28, 2017
Sawbros Industries Pvt., Ltd. Dhruv Sawhney Manager Regulatory A-68 Sector 2 Noida, Uttar Pradesh 201301 INDIA
Re: K162543
Trade/Device Name: Reverse Pull Adjustable Facemask Regulation Number: 21 CFR 872.5500 Regulation Name: Extraoral orthodontic headgear Regulatory Class: Class II Product Code: DZB Dated: July 6, 2017 Received: July 25, 2017
Dear Dhruv Sawhney:
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. The general controls provisions of the Actinclude 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 comples 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162543
Device Name Reverse Pull Adjustable Facemask
Indications for Use (Describe) Use as a treatment option for Class III malocclusion.
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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FORM FDA 3881 (8/14)
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SAWBROS INDUSTRIES Pvt. Ltd.
B(35, LAJPAT NAGAR – II, NEW DELHI – 110 024 INDIA TEL: +91(11(298(17252, +91(120(432(0244 E(MAIL: contact@sawbros.com
510(k) Summary
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.(c)
Submitter
807.92(a)(1)
| Name | Sawbros Industries Pvt., Ltd. |
|---|---|
| Address | B(35 Lajpat Nagar – II, |
| New Delhi 110024, | |
| India | |
| USFDA | |
| Registration No. | 3008959450 |
| Phone | +91(99(1111(7584 |
| Fax | +971(4(359(6556 |
| Contact | Dhruv Sawhney, Manager (Regulatory Affairs) |
| Date Prepared | 6th July 2017 |
U.S Contact
| Name | Mike Sobotka |
|---|---|
| Address | 124(02 Metropolitan Avenue, |
| Kew Gardens, | |
| NY 11415(2712 | |
| Phone | 718(441(0526 |
| Cell | 917(620(3091 |
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WBROS INDUSTRIES Pvt. Ltd.
B(35, LAJPAT NAGAR – II, NEW DELHI – 110 024 INDIA TEL: +91(11(298(17252, +91(120(432(0244 E(MAIL: contact@sawbros.com
807.92(a)(2)
Device Name:
| Trade Name | Reverse Pull Adjustable Facemask |
|---|---|
| Common Name | Orthodontic Facemask, Chin Cup, Adjustable Facemask, Reverse Pull Headgear |
| Classification Name | Extraoral Orthodontic Headgear |
| Regulation No. | 21CFR872.5500 |
| Classification Code | DZB |
807.92(a)(3)
Predicate Device
| Device Name | 510 (k) | Company Name | |
|---|---|---|---|
| Primary Predicate | MULTI ADJUSTABLE FACE MASK | K000358 | ORTHO |
| TECHNOLOGY |
807.92(a)(4)
Device Description
The Reverse Pull Adjustable Facemask is an extra oral device placed on the face of a patient. The subject device is provided assembled; packaged in a plastic heat sealed bag placed in a nylon pouch, to safeguard the integrity of the packaging. The device is provided non(sterile. No prior skin preparation is required to use the device. The skin contacting surfaces may require light cleaning with water between uses, depending on the patient's personal hygiene.
The subject device consists of a vertical main frame, made of 304(grade stainless steel, having adjustable supports for the patient's forehead and chin. The two supports are lined with Ethylene( Vinyl Acetate (EVA) plastic foam for patient comfort. Moreover, the forehead support has two vents
5
to allow airflow to skin in contact with the support. Two additional EVA pads for forehead and chin supports are included for patient comfort and hygiene.
An elastic capstan crossbar made of 304 grade stainless steel, with an allen screw is present on the vertical main frame between the forehead and chin support. The crossbar is utilized by the Orthodontic practitioner as a means of anchorage support for attaching elastics to intraoral appliances. Elastics or the intraoral appliances are not provided with this device.
| Model# | Description |
|---|---|
| 426(055RM | Reverse Pull Adjustable Facemask (Blue) |
| 426(056RM | Reverse Pull Adjustable Facemask (Teal) |
| 426(057RM | Reverse Pull Adjustable Facemask (Red) |
| 426(058RM | Reverse Pull Adjustable Facemask (Pearl) |
| 426(050RM | Chin Cup |
Table 1. List of models included within this submission
807.92(a)(5)
Indications for Use
Use as a treatment option for Class III malocclusion.
807.92(a)(6)
Basis for Substantial Equivalence
The Reverse Pull Adjustable Facemask has almost identical components and construction as the predicate device. The similarity in design and construction between the Reverse Pull Adjustable Facemask and the predicate device supports the equivalence of the Reverse Pull Adjustable Facemask for the indicated use as demonstrated in table 2.
| Table 2. Comparison of Subject device with Primary Predicate | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -------------------------------------------------------------- | -- | -- |
| Subject Device | Primary Predicate | |
|---|---|---|
| 510(K) Number | K162543 | K000358 |
| Device Name | Reverse Pull Adjustable Facemask | Multi Adjustable Facemask |
| Applicant | Sawbros Industries Pvt. Ltd. | Ortho Technology |
| Indication for | ||
| Use | Reverse Pull Adjustable Facemask is | |
| used as a treatment option for Class | ||
| III malocclusion. | Multi Adjustable Facemask is used | |
| as a treatment option for Class III | ||
| malocclusion. | ||
| Principle of | ||
| Operation | Extra oral anchorage support for | Extra oral anchorage support for |
| Operation | elastics from intra oral appliances. | elastics from intra oral appliances. |
| Anatomical | ||
| location of use | Face of patient. | Face of patient. |
| Patient Contact | Forehead and chin | Forehead and chin |
| Components | ||
| Main Frame | ||
| Material | 304 Stainless Steel | 304 Stainless Steel |
| Main Frame | ||
| Cross Section | 0.146"x0.116" | 0.140"x0.115" |
| Mobilisation | ||
| Screw on Chin | ||
| Cup | Allen Screw M3 length 4mm Present | Allen Screw M3 length 4mm Present |
| Chin Cup Support | ||
| material | EVA Plastic foam | EVA Plastic foam |
| Upper/Lower | ||
| Stop Screw for | ||
| Chin | Absent | Absent |
| Chin Cup | ||
| Mobility | Immobile during use | Immobile during use |
| Forehead | ||
| support material | EVA Plastic foam | EVA Plastic foam |
| Air Vents in | ||
| Forehead | ||
| Support | Present | Present |
| Crossbar | ||
| Construction | Capstan circular | Capstan circular |
| Crossbar | ||
| Material | 304 Stainless Steel | ABS Plastic |
| Protection | ||
| buttons end of | ||
| Main frame | Present | Present |
| Appliance | ||
| Weight | 1.86 oz | 1.90 oz |
| Screw | Allen Screw M3 length 4mm | Allen Screw M3 length 4mm |
| Time dependant | ||
| degradation | Low likelihood | Low likelihood |
| Appearance | Image: Blue orthodontic headgear | Image: Blue orthodontic headgear |
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7
As demonstrated in table 2, Reverse Pull Adjustable Facemask is substantially equivalent to the predicate device in terms of indications for use, material, composition and design.
807.92(b)(1)
Nonclinical Tests Discussion
Performance tests in accordance to ISO 6892(1:2016 for tensile testing of metallic materials at room temperature was conducted on the final finished device configuration as well as the predicate device to determine the equivalence. Biocompatibility was evaluated by preparing a risk assessment as per ISO 14971. The subject device has a similar tensile strength as the predicate and is therefore substantially similar to the predicate.
807.92(b)(2)
Clinical Tests Discussion
No clinical field trials have been conducted with Reverse Pull Adjustable Facemask.
807.92(b)(3)
Conclusion
The Reverse Pull Adjustable Facemask has an equivalent intended use, identical operation and substantially similar technological specifications as the predicate device. Based on the information provided in this premarket notification we conclude that the Reverse Pull Adjustable Facemask is equivalent as the predicate device.