HaloGUARD™ Protective Disc with CHG is intended to cover insertion sites on adult patients. Common applications include IV catheters, central venous lines, epidural catheters, PICCs, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices.

Device Description

HaloGUARD™ Protective Disc with CHG is a sterile, single use disposable disc infused with the antibacterial agent chlorhexidine gluconate (CHG).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "HaloGUARD™ Protective Disc with CHG", which is a medical device intended to cover insertion sites on adult patients. The submission argues for substantial equivalence to a predicate device, the "BIOPATCH Protective Disk with CHG".

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for K200641, the HaloGUARD™ Protective Disc with CHG, is based on a determination of substantial equivalence to a predicate device (BIOPATCH Protective Disk with CHG). Therefore, the "acceptance criteria" are primarily a demonstration that the subject device is as safe and effective as the predicate, without raising new questions of safety or effectiveness. The device performance is assessed through various non-clinical tests rather than specific clinical outcome metrics against predefined numerical targets.

Acceptance Criteria Category	Specific Criteria / Demonstrated Performance
Indications for Use	HaloGUARD™ Protective Disc with CHG is intended to cover insertion sites on adult patients. Common applications include: IV catheters, central venous lines, epidural catheters, PICCs, hemodialysis catheters, orthopedic pins, other intravascular catheters, and percutaneous devices. This is substantially equivalent to the predicate's use for absorbing exudate and covering wounds caused by various percutaneous medical devices.
Material	Medical grade foam impregnated with CHG with a film backing. Substantially equivalent to predicate.
Antibacterial Agent	Chlorhexidine gluconate (CHG). Substantially equivalent to predicate.
Sterilization Method	E-beam Radiation (35 kGy). Predicate uses Ethylene Oxide. This is a difference but deemed acceptable through testing.
Sterility Assurance Level	10⁻⁶. Substantially equivalent to predicate.
Shelf Life	Six (6) months. Predicate has two (2) years. This is a difference but a shorter shelf life is often acceptable if supported by data.
Biocompatibility	HaloGUARD™ Protective Disc with CHG is safe and effective for prolonged contact ( > 24 hours up to 30 days) with breached or compromised surfaces. Evaluated endpoints: Cytotoxicity, Irritation, Material-Mediated Pyrogenicity, Sensitization, Subacute Systemic Toxicity. Results demonstrate substantial equivalence.
Performance (Bench)	Met functional requirements. Evaluated aspects: Absorbency Factor, Antimicrobial Efficacy (4 log reduction and 7-day study) (USP <51>), Appearance, CHG Concentration Determination. Demonstrates substantial equivalence.
Wound Healing	Does not delay the natural wound healing response. Evaluated via an animal study (ISO 10993-6). Results demonstrate substantial equivalence.
Safety and Effectiveness	Overall conclusion that the device is substantially equivalent to the predicate, sharing similar design, indications, and technology, and raising no new questions of safety or effectiveness.

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

The document primarily describes non-clinical (bench and animal) testing. It does not mention a "test set" in the context of human patient data.
For bench testing: The phrase "representative finished, sterilized devices" is used. No specific numerical sample size is provided for these tests (Absorbency Factor, Antimicrobial Efficacy, Appearance, CHG Concentration Determination).
For biocompatibility testing: The phrase "representative finished, sterilized devices" is used. No specific numerical sample size is provided.
For animal study: "representative finished, sterilized devices" were used for the wound healing study. No specific numerical sample size (number of animals) is provided, nor is the country of origin of the study. This would be a prospective study on animals.
The document states: "Clinical testing was not required to support substantial equivalence." This means no human patient data (test set) was used.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

Not applicable as no clinical testing with human subjects or expert review of clinical cases was performed. The "ground truth" for the non-clinical tests is established by the respective test methodologies and standards (e.g., USP <51>, ISO standards).

4. Adjudication Method for the Test Set

Not applicable as no clinical testing with human subjects or expert review of clinical cases was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. Clinical testing was not required.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical disc, not an algorithm or AI-based product.

7. Type of Ground Truth Used

For biocompatibility: Ground truth is established by the specified ISO and USP standards (e.g., ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation).
For performance bench testing: Ground truth is established by internal test methods and USP <51> for antimicrobial efficacy (measuring log reduction).
For animal study (wound healing): Ground truth is established by ISO 10993-6 (Tests for Local Effects After Implantation).

8. Sample Size for the Training Set

Not applicable as this is not an AI/ML device that requires a training set. The device is a physical product.

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

Not applicable as this is not an AI/ML device.

Summary

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September 3, 2020

ATTWILL Medical Solutions Amarinder S. Gill Director of Quality 925 Development Drive Lodi, Wisconsin 53555

Re: K200641

Trade/Device Name: HaloGUARD Protective Disc with CHG Regulatory Class: Unclassified Product Code: FRO Dated: June 4, 2020 Received: June 5, 2020

Dear Amarinder S. Gill:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Anjana Jain, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200641

Device Name HaloGUARD™ Protective Disc with CHG

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1 Submitter

ATTWILL Medical Solutions 925 Development Drive Lodi, WI 53555 Phone: 608-592-6925

Amarinder S. Gill Director of Quality Email: sgill@attwillmedical.com

Preparation Date: September 3, 2020

2 Regulatory Information

Device Name: HaloGUARD™ Protective Disc with CHG Common Name: Dressing, Wound, Drug FDA Panel: General and plastic surgery Product Code: FRO Class: Unclassified

Predicate Device 3

K003229 – BIOPATCH Protective Disk with CHG

4 Device Description

HaloGUARD™ Protective Disc with CHG is a sterile, single use disposable disc infused with the antibacterial agent chlorhexidine gluconate (CHG). The average CHG concentration per disc is outlined in Table 1.

AVERAGE CONCENTRATION PER DISC
Model Number	Description	CHG Amount (mg)
HG0141	1 in disc, 4 mm hole	90
HG0171	1 in disc, 7 mm hole	85
HG0075151	0.75 in disc, 1.5 mm hole	51

Table 1. Average Cocentration per Disc

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5 Indications for Use

Substantial Equivalence Discussion 6

The review of the indications for use and comparison characteristics provided in Table 2 demonstrate that HaloGUARD™ Protective Disc with CHG is substantially equivalent to the predicate device, BIOPATCH Protective Disk with CHG.

Characteristic	Subject DeviceHaloGUARD™ Protective Disc withCHG K200641	Predicate DeviceBIOPATCH Protective Disk withCHG K003229
FDA Product Code	FRO	FRO
Indications for Use	HaloGUARD™ Protective Disc withCHG is intended to cover insertion siteson adult patients. Common applicationsinclude IV catheters, central venouslines, epidural catheters, PICCs,hemodialysis catheters, orthopedic pins,other intravascular catheters andpercutaneous devices.	BIOPATCH containing ChlorhexidineGluconate is intended for use as ahydrophilic wound dressing that is usedto absorb exudate and to cover a woundcaused by the use of vascular and non-vascular percutaneous medical devicessuch as: IV catheters, central venouslines, arterial catheters, dialysiscatheters, peripherally inserted coronarycatheters, mid-line catheters, drains,chest tubes, externally placed orthopedicpins, and epidural catheters. It is alsointended to reduce local infections,catheter-related blood stream infections(CRBSI), and skin colonization ofmicroorganisms commonly related toCRBSI, in patients with central venousor arterial catheters.
Single Use	Yes	Yes
Disposable	Yes	Yes
Material	Medical grade foam impregnated withCHG with a film backing with print	Medical grade foam impregnated withCHG with a film backing with print
Antibacterial Agent	Chlorhexidine gluconate (CHG)	Chlorhexidine gluconate (CHG)
Sterilization Method	E-beam Radiation	Ethylene Oxide
Sterility AssuranceLevel (SAL)	10-6	10-6

Table 2. Summary Comparison of Characteristics

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Characteristic	Subject DeviceHaloGUARD™ Protective Disc withCHG K200641	Predicate DeviceBIOPATCH Protective Disk withCHG K003229
Shelf Life	Six (6) months	Two (2) years
Biocompatible	Yes	Yes

7 Sterilization and Shelf Life

The subject device will be provided sterile via E-beam sterilization at a dose of 35 kGy. The shelf life for HaloGUARD™ Protective Disc with CHG is up to and no more than 6 months. The sterility tests of HaloGUARD™ Protective Disc with CHG have been proferomed on representative finished, sterilized devices as follow:

Bacterial Endotoxin USP <85>, FDA Recognized Standard 2-522 and USP <161>, . FDA Recognized Standard 2-523
Bioburden USP <51> ●

8 Biocompatibility

The results from the biocompatibility testing demonstrate that HaloGUARD™ Protective Disc with CHG is safe and effective, and substantially equivalent to the predicate device Biopatch for its intended use. The HaloGUARD™ Protective Disc with CHG indicated for prolonged contact with breached or compromised surfaces for > 24 hours and up to 30 days. Biocompatibility endpoints evaluated for HaloGUARD™ Protective Disc with CHG have been performed on representative finished, sterilized devices include:

. Cytotoxicity - ISO 10993-5 Tests for In Vitro Cytotoxicity, FDA Recognized Standard 2-245
Irritation ISO 10993-10 Tests for Irritation and Skin Sensitization, FDA Recognized . Standard 2-174
Material-Mediated Pyrogenicity ISO 10993-11 Tests for Systemic Toxicity, FDA . Recognized Standard 2-255
Sensitization ISO 10993-10 Tests for Irritation and Skin Sensitization, FDA ● Recognized Standard 2-174
Subacute Systemic Toxicity ISO 10993-11 Tests for Systemic Toxicity, FDA ● Recognized Standard 2-255

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Performance Testing - Bench ல்

The results from the performance bench testing demonstrate that HaloGUARD™ Protective Disc with CHG has met the functional requirements and is substantially equivalent to the predicate device. Performance bench tests of HaloGUARD™ Protective Disc with CHG have been performed on representative finished, sterilized devices as follows:

Absorbency Factor – Internal test method
Antimicrobial Efficacy (4 log reduction and 7 day study) USP <51> ●
Appearance Internal test method ●
CHG Concentration Determination Internal test method ●

10 Animal Studies

The results from the animal study demonstrate that HaloGUARD™ Protective Disc with CHG does not delay the natural wound healing response. The animal study of HaloGUARD™ Protective Disc with CHG has been performed on representative finished, sterilized devices as follows:

Wound Healing ISO 10993-6 Tests for Local Effects After Implantation, FDA ● Recognized Standard 2-247

11 Clinical Testing

Clinical testing was not required to support substantial equivalence.

12 Conclusion

The subject device HaloGUARD™ Protective Disc with CHG is substantially equivalent to the predicate device. HaloGUARD™ Protective Disc with CHG shares a substantially equivalent design, indications for use and technology (i.e. features, materials, and principles of operation) with the predicate device and no new questions of to safety or effectiveness have been identified.

Regulation Number and Section

N/A