(42 days)
K 123422
K 123422
No
The device is a cream intended for radiation shielding and does not involve any computational processing or algorithms.
No.
The device is described as a radiation shield intended to offer protection from radiation exposure, aligning more with preventative or protective measures rather than treating an existing condition or dysfunction.
No
Explanation: The device is an X-ray attenuating cream intended to shield hands from radiation during medical procedures, not to diagnose a condition.
No
The device is described as a "sterile cream" and its function is to provide radiation shielding through physical application. This is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The X-ray Attenuating Cream is a physical barrier applied to the skin or gloves to shield against radiation exposure during medical procedures. It does not analyze biological samples or provide diagnostic information about a patient's health.
- Intended Use: The intended use is for radiation protection of the user's hands, not for diagnosing or monitoring a patient's condition.
The device is a medical device, specifically a radiation shielding product, but it falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
PDK
Device Description
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 123422
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.6510 Cream for x-ray attenuation.
(a)
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.(b)
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.
0
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: (512) 560-8326 Cell: (512) 560-8326 Fax: (801) 254-4888 E-mail: rchowdhary@bloxr.com
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
1
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
2
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
(from / to) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | None |
| Radiation attenuation | None |
| Bio-compatibility | None |
| Compatibility with
gloves | Yes
(compatible with natural rubber
latex surgeons gloves /
compatible with natural rubber latex
surgeons gloves, and latex-free
poly-isoprene surgeon's gloves) |
| Packaging and
sterilization | None |
| Type of procedures
used for | None |
| Intended use | ... not intended to be used in or
adjacent to the primary beam.../
...not intended to be used in the
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
3
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.
4
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 (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/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 (800) 638-2041 or (301) 796-7100 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
5
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)
Smh?)
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6
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