ULTRABLOX

K133684 · Bloxr Corporation · PDK · Jan 13, 2014 · Radiology

Device Facts

• Record ID: K133684
• Device Name: ULTRABLOX
• Applicant: Bloxr Corporation
• Product Code: PDK · Radiology
• Decision Date: Jan 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.6510
• Device Class: Class 2

Intended Use

The UltraBLOX X-ray Attenuating Cream is intended for use as a radiation shield. It is intended to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The UltraBLOX X-ray Attenuating Cream is intended to be used during medical procedures where hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. NOTE: For use with natural rubber latex and latex-free poly-isoprene Surgeon's Gloves only.

Device Story

UltraBLOX is a sterile topical cream applied to hands as a radiation shield; used during fluoroscopy or radiography procedures where hands are exposed to radiation. Applied directly to skin before donning gloves or between two layers of gloves. Provides radiation attenuation up to 130 kVp. Used by physicians and surgical staff in clinical/surgical settings. Does not replace radiographic procedure gloves when hands are in the primary beam. Benefits include reduced radiation exposure to the user's hands.

Clinical Evidence

No clinical data. Bench testing only to demonstrate compatibility with latex-free poly-isoprene surgeon's gloves.

Technological Characteristics

Sterile topical cream. Radiation attenuation properties maintained up to 130 kVp. Compatible with natural rubber latex and latex-free poly-isoprene surgeon's gloves.

Indications for Use

Indicated for use as a radiation shield for clinicians' hands during medical procedures involving fluoroscopy or radiography (up to 130 kVp). Compatible with natural rubber latex and latex-free poly-isoprene surgeon's gloves.

Regulatory Classification

Identification

A cream for x-ray attenuation is a sterile cream intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. Cream for x-ray attenuation is intended to be used during medical procedures in which hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. Cream for x-ray attenuation is not intended to be used in or adjacent to the primary x-ray beam or the transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary x-ray beam.

Special Controls

In addition to the general controls of the FD&C Act, the X-ray Attenuating Cream is subject to the following special controls: The premarket notification submission must include results from safety and 1. effectiveness testing. The results from safety and effectiveness testing must include: Biocompatibility data consistent with the intended use for the device: a. Sterilization, packaging, and expiration date testing; and, b. Nonclinical and/or clinical performance testing representative of "as use" c. conditions demonstrating: i.compatibility to the type(s) of surgical glove (i.e., latex, nitrile, vinyl, etc.) to be used with the device: ii.attenuation performance; and, iii.proper application of the device. - 2. Labeling must include: - a. A statement that the device is sterile and an expiration date. b. A warning statement placed in a black box prominently placed in all labeling material for these devices. That warning statement must read: The device is not intended to be used in or adjacent to the primary X-ray beam or transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary X-ray beam. The methods and results from nonclinical and/or clinical performance C. testing representative of "as use" conditions demonstrating the amount of attenuation the device provides to the end user at 60, 80, 100, and 120 k Vp. Validated instructions for use for device application and state how often d. the device must be removed and reapplied for effective shielding. Identification of the type(s) of surgical glove (i.e., latex, nitrile, vinyl, etc.) e. that are compatible for use with the device.

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include documentation of results from safety and effectiveness testing. The results from safety and effectiveness testing must include: (i) Biocompatibility data consistent with the intended use for the device; (ii) Sterilization, packaging, and expiration date testing; and (iii) Nonclinical and/or clinical performance testing representative of “as use” conditions demonstrating: (A) Compatibility to the type(s) of surgical glove ( *e.g.,* latex, nitrile, vinyl) to be used with the device;(B) Attenuation performance; and (C) Proper application of the device. (2) Labeling must include: (i) A statement that the device is sterile and an expiration date. (ii) A boxed warning statement prominently placed in all labeling material for these devices. That boxed warning statement must read: “The device is not intended to be used in or adjacent to the primary X-ray beam or transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary X-ray beam.” (iii) The methods and results from nonclinical and/or clinical performance testing representative of “as use” conditions demonstrating the amount of attenuation the device provides to the end user at 60, 80, 100, and 120 kVp. (iv) Validated instructions for use for device application and a statement of how often the device must be removed and reapplied for effective shielding. (v) Identification of the type(s) of surgical glove ( *e.g.,* latex, nitrile, vinyl) that is compatible for use with the device.

Predicate Devices

• X-ray Attenuating Cream (K123422)

Submission Summary (Full Text)

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K133684
Page 1 of 3

# JAN 13 2014

# X-ray Attenuating Cream Section 5 -- 510(k) Summary

## 1 GENERAL INFORMATION

1.1 Submitter and Owner of the 510(k) BLOXR Corporation 960 Levoy Drive Salt Lake City. Utah 84123

#### 1.2 Official Correspondent

Rai Chowdhary Vice President of Operations and Engineering 960 Levoy Drive Salt Lake City, Utah 84123 Telephone: [phone] Cell: [phone] Fax: [phone] E-mail: [e-mail]

1.3 Date of Preparation Nov 25 2013

2 NAME OF THE DEVICE 2.1 Trade/Proprietary Name ULTRABLOX

## 2.2 Common/Usual Name

X-ray Attenuating Cream, or Cream for x-ray attenuation

#### 2.3 Classification Information

Classification Name: Cream for x-ray attenuation Classification Regulation: 21 CFR § 892.6510 Class: II Product Code: PDK Panel: Radiology

X-Ray Attenuating Cream

1 Nov 25 2013

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## 3 PREDICATE DEVICES

This device is the same X-ray Attenuating Cream that was cleared under the De Novo 510(k) K 123422, and classified as a Class II medical device. The device was earlier cleared for use with natural rubber latex surgical gloves only.

#### 4 DESCRIPTION OF THE DEVICE

The X-ray Attenuation Cream is a sterile cream intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The X-ray Attenuation Cream is intended for use during medical procedures in which hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 KVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. The X-ray Attenuation Cream is not intended to be used in the primary beam or the transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary x-ray beam.

## 5 INDICATIONS FOR USE AND INTENDED USE

The X-ray Attenuating Cream has the same intended use, and indications for use as before, with the addition of indications for use with poly-isoprene surgeon's gloves as below:

The X-ray Attenuating Cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The X-ray Attenuating Cream is intended to be used during medical procedures where hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures.

NOTE: For use with natural rubber latex and latex-free poly-isoprene Surgeon's Gloves only.

X-Ray Attenuating Cream

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K133684
Page 3 of 3

# 6 TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES

The X-ray Attenuating Cream is the same device that was cleared under De Novo 510(k) K123422. There is no change to packaging and sterilization. Since it is the same device, it has the same radiation attenuation and bio compatibility characteristics. The X-ray Attenuating Cream is now compatible for use with natural rubber latex, and latex-free poly-isoprene Surgeon's Gloves. The table below provides for a summary of what has changed in the X-ray Attenuating Cream.

| Characteristic | Change from Predicate<br>(from / to) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | None |
| Radiation attenuation | None |
| Bio-compatibility | None |
| Compatibility with<br>gloves | Yes<br>(compatible with natural rubber<br>latex surgeons gloves /<br>compatible with natural rubber latex<br>surgeons gloves, and latex-free<br>poly-isoprene surgeon's gloves) |
| Packaging and<br>sterilization | None |
| Type of procedures<br>used for | None |
| Intended use | ... not intended to be used in or<br>adjacent to the primary beam.../<br>...not intended to be used in the<br>primary beam... |

## X-ray Attenuating Cream vs. predicate X-ray Attenuating Cream

## 7 PERFORMANCE TESTING

The performance data presented in this 510(k) application demonstrate the X-ray Attenuating Cream can be used with latex-free poly-isoprene surgeon's gloves in addition to the previously cleared use with natural rubber latex surgeon's gloves.

## 8 CONCLUSIONS

This 510(k) submission provides the evidence that the X-ray Attenuating Cream is substantially equivalent to the device cleared under 510(k) K 123422.

X-Ray Attenuating Cream

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6 Silver Spring, MD 20993-0002

January 13, 2014

BLOXR Corporation % Mr. Prataprai (Rai) Chowdhary VP Operations and Engineering 960 Levoy Drive SALT LAKE CITY UT 84123

Re: K133684

Trade/Device Name: Ultrablox Regulation Number: 21 CFR 892.6510. Regulation Name: Cream for X-ray Attenuation Regulatory Class: II Product Code: PDK Dated: November 26, 2013 Received: December 2, 2013

Dear Mr. Chowdhary:

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 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 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2-Mr. Chowdhary

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,


for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known) K133684

#### Device Name

#### UltraBLOX X-ray Attenuating Cream

#### Indications for Use (Describe)

The X-ray Attenuating Cream has the same indications for use as the device cleared under 510(k) K 123422, with the addition of indications for use with poly-isoprene surgeon's gloves as below:

#### Device Name: X-ray Attenuating Cream

#### Indications for use:

The UltraBLOX X-ray Attenuating Cream is intended for use as a radiation shield. It is intended to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. The UltraBLOX X-ray Attenuating Cream is intended to be used during medical procedures where hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures.

NOTE: For use with natural rubber latex and latex-free poly-isoprene Surgeon's Gloves only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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