(42 days)
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.
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.
Acceptance Criteria and Study for X-ray Attenuating Cream (K133684)
This submission (K133684) is a 510(k) for an X-ray Attenuating Cream (Ultrablox) seeking to expand its indications for use to include compatibility with latex-free poly-isoprene surgeon's gloves, in addition to its previously cleared use with natural rubber latex surgical gloves. The original device was cleared under De Novo 510(k) K123422.
Given that this 510(k) is for an expansion of use for an already cleared device, and the primary change is compatibility with a different type of glove, the performance testing focuses on demonstrating this compatibility. The document explicitly states: "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."
Therefore, the acceptance criteria and study design are centered around confirming that this new compatibility does not negatively impact the device's function or safety, implicitly relying on the original clearance (K123422) for the core performance aspects (radiation attenuation and biocompatibility).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table for this 510(k) submission (K133684). This is because the device itself (its composition, radiation attenuation, and biocompatibility) has not changed from the predicate device (K123422). The "performance testing" described is to demonstrate compatibility with a new glove material.
However, based on the principle of substantial equivalence for this type of submission, the implicit acceptance criteria and reported performance are:
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Compatibility with Latex-Free Poly-isoprene Gloves | The X-ray Attenuating Cream, when used with latex-free poly-isoprene surgeon's gloves, must maintain its intended function as a radiation shield. | "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..." |
| Material Degradation / Impact on Glove Integrity | The cream should not degrade the integrity or performance of the latex-free poly-isoprene gloves. | (Implied by the statement of "compatibility"; no issues reported) |
| Radiation Attenuation | The radiation attenuation characteristics of the cream remain unchanged, regardless of the glove material. | "Radiation attenuation: None [change from predicate]" |
| Biocompatibility | The biocompatibility of the cream remains unchanged. | "Bio-compatibility: None [change from predicate]" |
| Packaging and Sterilization | Packaging and sterilization methods remain unchanged and effective. | "Packaging and sterilization: None [change from predicate]" |
| Intended Use | The intended use and indications for use remain consistent with the predicate, with the addition of poly-isoprene glove compatibility. | "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..." |
2. Sample Size Used for the Test Set and Data Provenance
The document for K133684 does not specify a separate "test set" with a sample size in the conventional sense (e.g., patient data, image dataset). The "performance testing" referenced appears to be focused on material compatibility testing rather than a clinical study. The details of the "performance data" are not provided in this summary but are stated to demonstrate compatibility.
Therefore, based on the provided document:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. It is likely laboratory-based material compatibility testing rather than clinical data from a specific country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this 510(k) submission. The "performance testing" detailed in this summary relates to material compatibility, not the assessment of imaging data or clinical outcomes that would require ground truth established by experts like radiologists or pathologists.
4. Adjudication Method for the Test Set
This information is not applicable to this 510(k) submission, as it does not involve assessment of imaging data or clinical scenarios requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done. This type of study would be relevant for evaluating the performance of an AI algorithm in an imaging context, which is not the subject of this medical device submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was not done. This submission is for an X-ray attenuating cream, not a digital algorithm or AI-powered device.
7. Type of Ground Truth Used
This information is not applicable to this 510(k) submission. The "ground truth" for material compatibility would typically be based on established material science standards, physical testing, or chemical analysis, not expert consensus, pathology, or outcomes data in a clinical sense. The document implies that the "performance data" collected confirmed the physical and chemical compatibility of the cream with poly-isoprene gloves.
8. Sample Size for the Training Set
This information is not applicable to this 510(k) submission. There is no AI or machine learning component requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable to this 510(k) submission, as there is no training set.
§ 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.