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KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using:

· Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200.

· 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 43.3 °C for models KC100 and KC200.

KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC100, KC200) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles.

These models of the KIMGUARD* ONE-STED* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 2)

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectanqular fabric produced using a three-layer SMS (spunbond-meltblown-spunbond) process. The wrap fabric (white or blue color) is composed of polypropylene with the addition of less than 2% by weight of phthalocvanine blue pigment (blue fabric only), less than 1% by weight titanium dioxide pigment, and less than 0.009% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

This FDA 510(k) summary describes KIMGUARD® ONE-STEP® Sterilization Wrap intended to enclose medical devices for sterilization and maintain sterility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for the "Maintenance of 365-Day Package Integrity," "Sterilant Penetration," and "Biocompatibility" tests. For the KIMGUARD® ONE-STEP® Sterilization Wrap Recommendations for Use (Table 1), the "test set" can be considered the specific configurations of loads used to validate the maximum wrapped package content weights:

• KC100: 16 huck towels (17"x 29") weighing 3 lbs.
• KC200: 2 huck towels (17"x 29"), 2 fluid resistant U-drapes (68"x 109"), 1 fluid resistant universal bar drape (70" x 108") weighing 6 lbs.

The data provenance is not explicitly mentioned as country of origin, but the applicant is Halyard Health, located in Alpharetta, GA, USA. The studies appear to be prospective as they were conducted to validate the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This product is a sterilization wrap, not an AI/imaging device. Therefore, the concept of "experts" to establish ground truth in the context of diagnostic interpretation is not applicable here. The validation involves standardized performance tests for sterilization and material properties. Compliance with relevant standards (e.g., ISO 10993 for biocompatibility) would be performed by qualified personnel in testing laboratories.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device and study. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers.

5. 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/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI software. The device itself (the sterilization wrap) has a standalone performance (its ability to maintain sterility and allow sterilant penetration). The nonclinical tests essentially evaluate this "standalone" performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by:

• Quantitative measurements and observations based on standardized test methods for:
  • Sterilant penetration (ensuring the sterilant reaches the enclosed medical device).
  • Microbiological challenge (implied by "maintenance of sterility" tests, indicating no microbial ingress).
  • Physical integrity tests to confirm the wrap remains intact over time, preventing contamination.
  • Biocompatibility tests according to ISO standards, which involve specific physiological responses.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable as there is no training set for this device.

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KIMGUARD ONE-STEP® Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

• V-PRO® 60 Low Temperature Sterilization System that include:
  • o Lumen Cycle
  • Non Lumen Cycle o
  • Flexible Cycle O

KIMGUARD* ONE-STEP® Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD* ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.

The blue or white sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The blue wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of anti-static treatment. The white sheet has the same material composition but contains no blue pigment. The wrap allows a sterilized package to be opened aseptically.

I am sorry, but based on the provided document, the information required to compose the detailed response for "acceptance criteria and the study that proves the device meets the acceptance criteria" as requested is not available. The document is a 510(k) summary for a sterilization wrap, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics in the format requested for a device that typically involves AI or human interpretation.

Specifically, the document states:

• "All results of testing met acceptance criteria demonstrating that the KIMGUARD* ONE-STEP® Sterilization Wrap allows sterilization of contents by the V-PRO® 60 Low Temperature Sterilization System (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) and maintains sterility of contents until used."
• It lists a "Summary of Testing Performed" table with "Results" as "Passed" for "Sterilant Penetration", "Maintenance of Package Integrity (30 Days)", "Performance Testing", and "Material Biocompatibility."

However, it does not provide:

1. A table of specific acceptance criteria and reported device performance (e.g., quantifiable metrics like sensitivity, specificity, accuracy, or other performance thresholds with numerical results). The results are simply stated as "Passed."
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications used to establish ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document describes a medical device (sterilization wrap) which functions as a physical barrier and facilitator of sterilization, not an AI-powered diagnostic or interpretive device. Therefore, the types of studies and performance metrics typically associated with AI/software-as-a-medical-device (SaMD) are not applicable here.

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KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 STERRAD® NX® [Standard Cvcle. Advanced Cvcle] STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO Cycle]

KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC300, KC400, KC500, and KC600) allowed sterilization of the enclosed devices by the Advanced Sterilization Products STERRAD® Sterilization Systems (STERRAD® 50, 100S, 200, NX® [Standard Cycle and Advanced Cycle] and 100NX® [Standard Cycle, EXPRESS Cycle, DUO Cycle]).

The KIMGUARD* ONE-STEP* Sterilization Wrap (Models KC300, KC400, K500, KC600) have been validated for use with the STERRAD® 50, STERRAD® 100S, STERRAD® 200, STERRAD® NX® and STERRAD® 100NX® cycles in Table 1.

KIMGUARD* ONE-STEP* Sterilization Wrap Recommendations for Use with the Advanced Sterilization Products STERRAD® Sterilization Systems are provided in Table 2.

KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two edges. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbond-meltblown-spunbond) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

The acceptance criteria are that the KIMGUARD® ONE-STEP® Sterilization Wrap maintains sterility until used, after being sterilized by the referenced STERRAD® Sterilization Systems.

Here's the summary of the study:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the specific sample sizes for each test in the test set. It mentions "Test results validated" and "Performance testing was conducted," implying a test set was used. The data provenance is not specified (e.g., country of origin). It's a nonclinical study, so it wouldn't be retrospective or prospective in the human study sense.

3. Number of Experts and Qualifications for Ground Truth of Test Set:
This information is not provided in the document. As this is a non-clinical device (sterilization wrap), it's unlikely that "experts" in the medical sense (like radiologists) were used to establish ground truth for performance tests like package integrity or sterilization efficacy. Ground truth would be based on validated scientific and engineering testing protocols.

4. Adjudication Method for the Test Set:
The document does not mention an adjudication method. For non-clinical performance tests, adjudication (e.g., 2+1, 3+1 for human readers) is typically not applicable. The results are usually objectively measured against predefined pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or evaluative devices where human interpretation is involved. This device is a sterilization wrap, and its effectiveness is determined by objective physical and biological tests.

6. Standalone Performance:
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done, as this is a physical product being tested for its intrinsic performance (package integrity, ability to allow sterilization). The study involved "Performance testing" and "nonclinical tests" as described.

7. Type of Ground Truth Used:
The ground truth used for these tests would be based on:

• Standardized microbiological testing (to confirm sterilization efficacy and sterility maintenance).
• Physical integrity testing methods (to assess package integrity).
• Chemical indicators or biological indicators (for sterilization effectiveness).
• The tests adhere to established standards and protocols for sterilization validation and sterile barrier system performance.

8. Sample Size for the Training Set:
The concept of a "training set" is not applicable here as this is a physical device being evaluated for its performance through testing, not an AI/algorithm being trained on data.

9. How the Ground Truth for the Training Set Was Established:
As mentioned in point 8, the concept of a "training set" is not applicable to this type of device and study.

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KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

• Gravity Steam at 250°F/121°C for 30 minutes. .
  KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200, KC300, KC400, KC500 and KC600) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD* ONE-STEP* Sterilization Wrap is comprised of two sheets of KIMGUARD* Sterilization Wrap that is ultrasonically seamed on two edges. This seamed configuration allows for convenient wrapping of an article using two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a threelayer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of antistatic treatment. The wrap allows a sterilized package to be opened aseptically.

Here's an analysis of the provided text regarding the acceptance criteria and study for the KIMGUARD ONE-STEP Sterilization Wrap:

Acceptance Criteria and Device Performance for KIMGUARD® ONE-STEP® Sterilization Wrap

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All results of testing met the same acceptance criteria as the predicate devices demonstrating substantial equivalence to the predicate devices." While specific, numerical acceptance criteria are not explicitly detailed (e.g., minimum tensile strength), the "Passed" designation for each category indicates successful fulfillment of the established criteria, which are identical to those of the predicate devices (K082177 and K091685). The specific loads and weights for each wrap model also represent acceptance criteria for their respective uses.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific numerical sample size used for the test sets (e.g., how many wraps were tested for sterilant penetration). However, it lists the types of loads used in the "Sterility Maintenance Validation Study" for each wrap model:

• KC100: 1 tray liner 20" x 25", 12.5" x 9" x 1" Tray, 1 lb of metal mass
• KC200: 1 tray liner 20" x 25", 10" x 20" x 3 ½ Tray, 3 lbs of metal mass
• KC300: 1 tray liner 20" x 25", 10" x 20" x 3 ½Tray, 6 lbs of metal mass
• KC400: 1 tray liner 20" x 25", 10" x 20" x 3 ½ Tray, 10 lbs of metal mass
• KC500: 1 tray liner 20" x 25", 11" x 22" x 3 ½Tray, 12 lbs of metal mass
• KC600: 1 tray liner 20" x 25", 11" x 22" x 3 ½Tray, 20 lbs of metal mass

The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It is implied to be prospective testing conducted for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests described are nonclinical, laboratory-based performance tests rather than studies requiring human expert interpretation for ground truth establishment.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as the tests are nonclinical performance evaluations rather than interpretive studies requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically for evaluating diagnostic or interpretive AI systems, not packaging materials.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical sterilization wrap, not an algorithm or AI system. The performance evaluation is inherently "standalone" in the sense that it assesses the physical product's characteristics and functionality.

7. The Type of Ground Truth Used

The ground truth for the nonclinical tests appears to be established scientific and regulatory standards/methods for sterilization packaging performance. This would include methods for assessing sterilant penetration, package integrity (e.g., burst strength, seal integrity), drying, aeration, and maintenance of sterility (e.g., microbial barrier testing). The "results of testing met the same acceptance criteria as the predicate devices," implying a comparison against established performance benchmarks for similar products.

8. The Sample Size for the Training Set

This is not applicable. The KIMGUARD ONE-STEP Sterilization Wrap is a physical medical device, not an AI or Machine Learning algorithm that requires a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

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KIMGUARD* ONE-STEP* Sterilization Wraps are intended to enclose another medical device that is to be sterilized by a healthcare provider using:

• Advanced Sterilization Products STERRAD® Sterilization Systems that include: STERRAD® 50, 100S, and 200 o
  • STERRAD® NX® [Standard Cycle, Advanced Cycle] o
  • STERRAD® 100NX® [Standard Cycle, Flex Cycle, EXPRESS Cycle, DUO o Cycle]

KIMGUARD* ONE-STEP* Sterilization Wraps are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used.

KIMGUARD® ONE-STEP® Sterilization Wrap is comprised of two sheets of KIMGUARD® Sterilization Wrap ultrasonically seamed on two sides. This allows for convenient wrapping with two sheets simultaneously.

The sheets of sterilization wrap are square or rectangular fabric produced using a three-layer SMS (spunbound-meltblown-spunbound) process. The wrap fabric is composed of polypropylene with the addition of less than 2% by weight of phthalocyanine blue pigment, less than 1% by weight titanium dioxide pigment, and less than 0.008% by weight of a potassium phosphate anti-static treatment. The wrap allows a sterilized package to be opened aseptically.

The provided text describes the KIMGUARD® ONE-STEP® Sterilization Wrap and validation studies demonstrating its performance. However, it does not involve an AI device or a study comparing AI with human readers. Therefore, several sections of your request are not applicable.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample sizes (e.g., number of wraps, number of sterilization cycles, number of instruments) used for the performance tests (Sterilant Penetration, Package Integrity, Maintenance of Package Integrity, Material Compatibility, Shelf Life, Biocompatibility).
   • The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a performance study for a physical medical device (sterilization wrap), not an AI diagnostic device requiring expert ground truth establishment.

3. Adjudication method for the test set: Not applicable. (See point 2)

4. 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 device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established through objective engineering and microbiological testing standards for sterilization wraps. This involves:

   • Verification of the ability to allow sterilant penetration.
   • Demonstration of package integrity (e.g., preventing microbial ingress).
   • Proof of material compatibility with sterilization methods.
   • Shelf life studies to ensure long-term integrity.
   • Biocompatibility testing to ensure safety of the material.
   • These are based on established scientific and regulatory guidelines for sterilization products.

7. The sample size for the training set: Not applicable. This is not an AI model, so there is no training set.

8. How the ground truth for the training set was established: Not applicable. (See point 7)

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