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. X-ray Attenuating cream 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.

Device Description

The subject device is an X-ray attenuating cream that utilizes bismuth oxide powder as the X-ray absorber material. The subject device is provided sterile in a tube for single use. The end user is to squeeze all of the cream out, either directly to the health care professional's hands or onto a surgical glove before donning a second glove. The device provides protection from X-rays and scatter radiation during procedures where the health care professional's hands are necessarily exposed to radiation.

AI/ML Overview

The provided text describes the BloXR X-ray Attenuating Cream, its intended use, and the regulatory decision for its classification. However, the document does not contain the specific details about a study comprehensively proving the device meets acceptance criteria in the manner requested (i.e., comparing algorithmic performance to ground truth or human readers).

The document focuses on:

Regulatory classification of the device (Class II, Product Code PDK).
Indications for Use and Limitations.
Device Description and Principle of Operation.
Summary of Nonclinical/Bench Studies: These address biocompatibility, shelf-life/sterility, and performance testing related to X-ray attenuation.
Labeling requirements and content: This includes information about % attenuation at different kVp levels.
Identified Risks and Required Mitigation Measures: This details potential adverse tissue reactions, infection risk, and radiation exposure due to various factors, along with mitigation strategies.
Special Controls: These outline the required testing (biocompatibility, sterilization, performance testing for glove compatibility, attenuation, and application) and labeling statements.
Benefit/Risk Determination.

The key information requested regarding acceptance criteria and performance data in a structured study for an AI/ML medical device (e.g., sample sizes, data provenance, expert ground truth, MRMC studies, standalone performance) is not present in this document because the BloXR X-ray Attenuating Cream is a physical product (a cream), not an AI/ML algorithm or system.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML study design.

However, I can extract the acceptance criteria related to radiation attenuation and the reported performance from the labeling section as provided in the document.

1. Table of Acceptance Criteria (as per labeling) and Reported Device Performance (as presented in the document):

kVp	Acceptance Criteria (% Attenuation stated in labeling)	Reported Device Performance (% Attenuation from labeling)
60	80%	80%
80	75%	75%
100	65%	65%
120	60%	60%

Note: The document explicitly states: "The labeling includes the table shown below of the % attenuation the end user can expect the device will provide if applied correctly." This implies these values from the "Performance Testing – Bench" section (of which the specific data is redacted, but summarized in the labeling) are the reported performance confirming the device meets what it claims to achieve.

Regarding the other requested information, as explained above, it is not applicable or not present in this document as it pertains to AI/ML device studies:

Sample size used for the test set and the data provenance: Not applicable for a physical cream; no "test set" in the context of an AI/ML algorithm. The performance data is from "Nonclinical/Bench Studies." The specific number of tests or samples for these bench studies is redacted (indicated by (b)(4)).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for radiation attenuation is based on physical measurement, not expert consensus.
Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used: For attenuation, the ground truth is likely established through standardized physical measurements in a laboratory setting. For biocompatibility, it's toxicology/biological response data.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

Evidence of Meeting Acceptance Criteria: The document explicitly states, "The labeling includes the table shown below of the % attenuation the end user can expect the device will provide if applied correctly." The percentages in this table match the "Manufacturer performance claims" (though the full table from the manufacturer is redacted). This indicates that the device's measured performance in bench testing aligned with the stated attenuation percentages provided to the user in the labeling, which serve as the practical acceptance criteria for its core function.
Study Type: Nonclinical/Bench Studies (physical performance testing, biocompatibility, shelf-life, sterility).
Ground Truth: For radiation attenuation, this would be objective physical measurements of X-ray transmission through the cream under controlled conditions. For biocompatibility, it's standardized biological assays (Cytotoxicity, Sensitization, Skin Irritation, Acute Systemic Toxicity).
Limitations: This document is a regulatory decision summary and, by its nature, may redact specific proprietary information like detailed test reports, raw data, or exact sample sizes, indicated by "(b)(4)".

Summary

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DE NOVO CLASSIFICATION REQUEST FOR

BloXR X-ray Attenuating Cream

DECISION SUMMARY

Regulatory Information: 1.

Identification a.

FDA identifies this type of device as:

Cream for x-rav attenuation

Cream for x-ray attenuation is a 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.

New Regulation Number: 21 CFR 892.6510 b.
Classification: Class II C.
d. Product Code: PDK

2. Background

Device Name: X-ray Attenuating Cream a.
b. Submission number: K123422
Date of De Novo Request: February 4, 2013 C.

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Contact in USA: Mr. Prataprai (Rai) Chowdhary d. VP of Operations & Engineering 960 West Levoy Drive, Suit 100 Salt Lake City, UT 84123 TEL: 801 590 9884 FAX: 877 254 4888 EMAIL: rchowdhary@bloxr.com

Requester's Recommended Classification: Class II e.

3. Indications for use

Limitations a.

This is a prescription device regulated under 21 CFR 801.109.

Note: For use with natural rubber latex Surgeon's Gloves only.

. A warning statement placed in a black box must be prominently placed in all labeling material for this device. 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.

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Device Description 4.

a. Device description:

b. Principle of Operation:

Radiation is blocked by the device via absorption of the photon energy from ionizing radiation. This photon energy is dissipated as phonon energy within the atomic lattice structure of the radiation absorber material (bismuth oxide).

ട. Summary of Nonclinical/Bench Studies

Nonclinical performance data were provided to address the following areas:

Biocompatibility/Materials a.

Biocompatibility testing was submitted for the subject device which is intended for skin contact with the health care professional for less than 24 hours. Testing included Cytotoxicity in accordance with ISO 10993-5, Sensitization in accordance with ISO 10993-10, Skin irritation in accordance with ISO 10993-10, and Acute Systemic toxicity in accordance with ISO 10993-11. Acute systemic toxicity testing was conducted in the event that the surgical glove fail and some of the subject device flakes off the healthcare professional's hand into an open surgical site into the patient.

b. Shelf Life/Sterility

Image /page/2/Picture/10 description: The image shows the text "(b) (4)" in red font. The text is located in the top left corner of the image. The background of the image is black.

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Electromagnetic Compatibility and Electrical Safety C.

Not applicable

Software d.

Not applicable

Performance Testing – Bench e.

Image /page/3/Picture/5 description: The image is a black screen with the text '(b) (4)' in the upper left corner. The text is red. The background is completely black, with no other objects or features visible.

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		Manufacturer performance
	BloXR	claims
(b) (4)

Table 1: Mean % Attenuation, BloXT vs. Predicate Gloves

Image /page/4/Figure/2 description: The image shows the title of a table, which is "Table 2: Average % Attenuation of Cream and Radion-X Glove". The image also contains the labels (b) and (4). The table likely contains data about the average percentage of attenuation for cream and Radion-X gloves.

Image /page/4/Figure/3 description: The image shows the text "(b) (4)" in red font. The text is located in the top left corner of the image. The background of the image is black.

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Image /page/5/Picture/0 description: The image is completely black, with the exception of the text '(b) (4)' in the upper left corner. The text is written in red. The rest of the image is a solid black color, with no other visible elements or features.

f. Performance Testing – Animal &/or Cadaver
Image /page/5/Picture/2 description: The image shows the text '(b) (4)' in red font. The text is located in the upper left corner of the image. The background of the image is black.
Summary of Clinical Information 6.
Image /page/5/Figure/4 description: The image is a black background with the text '(b) (4)' in the upper left corner. The text is written in red. The background is completely black, and the text is the only visible element in the image. The text is small and simple.

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(b) (4)

7. Labeling

The labeling is sufficient and satisfies the requirements of 21 CFR 801.109 Prescription devices.

Of particular note the labeling meets the requirements in the special controls:

The device labeling must include a statement notifying the end user that the a. device is sterile and provide an expiration date.
The labeling includes an expiration date which has been specified as 9 months and states that the device is sterile until opened. The device labeling also states that it is for single use.
b. A warning statement placed in a black box must be 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 labeling has included the contraindication statement as requested in a black box warning.

C. Labeling must present the methods and results from nonclinical and/or clinical performance testing representative of "as use" conditions

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demonstrating the amount of attenuation the device provides to the end user at 60, 80, 100, and 120 kVp.

The labeling includes the table shown below of the % attenuation the end user can expect the device will provide if applied correctly.

kVp	% Attenuation
60	80
80	75
100	65
120	60

The sponsor has also provided Tables 1 – 3 shown above in the labeling along with the testing method.

d. Labeling must include validated instructions for use for device application and state how often the device must be removed and re-applied for effective shielding.

The instructions for glove application include the following: Squeeze out entire contents of tube and apply to hands evenly to create a uniform opaque coating. Allow to dry for up to 60 seconds before putting on surgeon's gloves. Or, you may apply the cream to uniformly coat the first glove; allow to dry for up to 60 seconds, before putting on the second surgeon's glove. Check to make sure cream is completely encapsulated within gloves. Once applied on the hand or glove, the cream shall be used for a maximum period of three hours.

Labeling must identify the type(s) of surgical glove (i.e., latex, nitrile, vinyl, e. etc.) that are compatible for use with the device.

The labeling states that the cream is for use with latex gloves only.

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Risks to Health and Required Mitigation Measures 8.

FDA has identified the risks of cream for x-ray attenuation as:

Adverse tissue reaction to health care professionals and patients as a result of a. direct contact to the skin. Health care professionals may apply the cream directly to their hands for use. Patients may be exposed to the cream as a result of glove failure due to incompatibility with the cream formulation weakening the mechanical characteristics of the surgical gloves. The adverse tissue reaction would be due to toxic, irritating, or sensitizing agents present in the cream formulation.
Infection risk to patient as a result of patient contact with b. contaminated/compromised cream due to glove failure. Glove failure could occur due to incompatibility with the cream formulation weakening the mechanical characteristics of the surgical gloves. Infection to the patient could occur as a result of non-sterile cream, contaminated/compromised cream and loss of the sterile boundary due to glove failure.
Radiation exposure to health care professionals due to lack of radiation C. attenuation. Lack of radiation can occur due to inadequate or inconsistent cream formulation. The radiation attenuating agent in the cream may not be present in high enough concentration or is not appropriate to provide the amount of protection needed.
Radiation exposure to health care professional during actual use (lack of d. effectiveness). Lack of continuous protection during actual use can result from poor cream composition such that the cream will absorb, crack, flake off, etc. during use in a clinical setting.
f. Radiation exposure to health care professionals due to inconsistent device application. Radiation exposure can result due to inadequate instructions describing how to apply the cream and how often to reapply the cream to ensure that the hands are completely covered and covered with enough cream to provide the amount radiation protection stated in the labeling.

Table - Identified Potential Risks and Required Mitigation Measures

Identified Potential Risks	Required Mitigation Measures
Adverse tissue reaction to health care professionals	(1) Biocompatibility testing
and patients as a result of direct contact to the skin.	(2) Surgical glove compatibility performancetesting(3) Identification of compatible surgical gloves inlabeling
Infection risk to patient as a result of patientcontact with contaminated cream due to glovefailure and the cream flaking off onto the patient.	(1) Sterilization, packaging, and expiration datetesting.(2) Sterile device and expiration date statement inlabeling(3) Surgical glove compatibility performancetesting
	(4) Identification of compatible surgical gloves inlabeling
Radiation exposure to health care professionals dueto lack of radiation attenuation because of creamformulation. The radiation attenuating agent in thecream may not be present in high enoughconcentration or is not appropriate to provide theamount of protection needed.	(1) Black box warning in labeling(2) Attenuation information in labeling(3) Surgical glove compatibility performancetesting(4) Attenuation performance testing(5) Application performance testing
Radiation exposure to health care professionalduring actual use (lack of effectiveness). Lack ofcontinuous protection during actual use can resultfrom poor cream composition such that the creamwill absorb, crack, flake off, etc. during use in aclinical setting.	(1) Black box warning in labeling(2) Attenuation information in labeling(3) Surgical glove compatibility performancetesting
	(4) Attenuation performance testing
	(5) Application performance testing
	(6) Validated device application instructions foreffective shielding in labeling
Radiation exposure to health care professionals dueto inconsistent device application. Radiationexposure can result due to inadequate instructionsdescribing how to apply the cream to ensure thatthe hands are completely covered and covered withenough cream to provide the amount of radiationprotection stated in the labeling.	(1) Validated device application instructions foreffective shielding in labeling

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9. 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.

1. 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.

10. Benefit/Risk Determination

Risks a.

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The risks of the device are based on the indications for use for the device and the data collected from the bench and clinical data described above. These risks include:

Adverse tissue reaction to health care professionals and patients as a result of ● direct contact to the skin.
. Infection risk to patient as a result of patient contact with contaminated cream due to glove failure and the cream flaking off onto the patient.
. Radiation exposure to health care professionals due to lack of radiation attenuation because of cream formulation. The radiation attenuating agent in the cream may not be present in high enough concentration or is not appropriate to provide the amount of protection needed.
. Radiation exposure to health care professional during actual use (lack of effectiveness). Lack of continuous protection during actual use can result from poor cream composition such that the cream will absorb, crack, flake off, etc. during use in a clinical setting.
Radiation exposure to health care professionals due to inconsistent device ● application. Radiation exposure can result due to inadequate instructions describing how to apply the cream to ensure that the hands are completely covered and covered with enough cream to provide the amount of radiation protection stated in the labeling.

b. Benefits

The probably benefits of the device are also based on the indications for use of the device, known standard operating procedures of health service providers, and the bench and clinical testing date described above. The summary benefits include:

Improved X-ray radiation attenuation properties compared to most X-ray attenuating gloves currently on the market.
. Allows the health care professional to maintain their tactile dexterity that would be lost with the thicker Radiographic procedure gloves.
The device is biocompatible for the intended use ●
The device is compatible with latex gloves ●
. The device is provided sterile

Summary of Other Factors C.

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The device is intended to be used only with latex gloves and no other glove ● type.
The sponsor has added the black box warning statement that the subject ● device is not 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.
Labeling includes the expected amount of attenuation the device provides to ● the end user at 60, 80, 100, and 120 kVp.
Labeling includes instructions for device application and also states how often the device must be removed and reapplied for effective shielding.
. Labeling includes a statement that the device is sterile and provides an expiration date.
Biocompatibility data was included in the premarket notification submission consistent with the intended use for the device.
. Nonclinical and clinical performance testing was included in the premarket notification submission demonstrating (a) the device's compatibility to surgical gloves (i.e., latex, nitrile, vinyl, etc.), (b) the device's attenuation ability and efficacy, and (c) testing to ensure proper application of the device.

d. Assessment of Benefit and Risks

In conclusion, the bench testing and clinical testing indicate that the probability of risks for the subject device is similar to those for X-ray attenuating gloves. The benefits the subject device provides in terms of X-ray attenuation are equivalent or better than the X-ray attenuating gloves currently available on the market. As such the benefit to risk ratio is high for the subject device.

【

Other comments 11.

None

12. Conclusion:

The de novo for the BloXR X-ray Attenuating Cream is granted and the device is classified under the following:

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Product Code: PDK a.
Device Type: Cream for x-ray attenuation b.
Class: Class II c.
d. Regulation: 21 CFR 892.6510

Regulation Number and Section

§ 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.