Who is the manufacturer of HaloGUARD Protective Disc with CHG?

Attwill Medical Solutions filed the 510(k) submission for HaloGUARD Protective Disc with CHG (K200641).

What is the FDA product code for HaloGUARD Protective Disc with CHG?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for HaloGUARD Protective Disc with CHG?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HaloGUARD Protective Disc with CHG?

BIOPATCH Protective Disk with CHG (K003229).

Who can help prepare an FDA 510(k) submission like HaloGUARD Protective Disc with CHG?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HaloGUARD Protective Disc with CHG

K200641 · Attwill Medical Solutions · FRO · Sep 3, 2020 · SU

Device Facts

Record ID	K200641
Device Name	HaloGUARD Protective Disc with CHG
Applicant	Attwill Medical Solutions
Product Code	FRO · SU
Decision Date	Sep 3, 2020
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended 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.

Device Story

Sterile, single-use, disposable foam disc impregnated with chlorhexidine gluconate (CHG); intended for application over percutaneous insertion sites (e.g., IV catheters, central venous lines, orthopedic pins) in adult patients. Device functions as a wound dressing to cover insertion sites. Applied by healthcare providers in clinical settings. CHG agent provides antimicrobial properties at the site. Benefits include protection of insertion sites and potential reduction of skin colonization. Device is provided sterile via E-beam radiation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (absorbency, antimicrobial efficacy, CHG concentration) and animal studies (wound healing per ISO 10993-6). Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity).

Technological Characteristics

Medical grade foam impregnated with CHG; film backing with print. Sterilization: E-beam radiation (35 kGy). SAL 10^-6. Biocompatibility per ISO 10993-5, 10, 11. Shelf life: 6 months.

Indications for Use

Indicated for adult patients to cover insertion sites of intravascular catheters (IV, central venous, PICCs, hemodialysis), epidural catheters, orthopedic pins, and other percutaneous devices.

Predicate Devices

BIOPATCH Protective Disk with CHG (K003229)

Related Devices

K133764 — CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL · Avery Dennison Belgie Bvba · Mar 13, 2014
K120930 — CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING · Medtrade Products , Ltd. · Oct 26, 2012
K152923 — BD ChloraShield IV Dressing with CHG Antimicrobial · Avery Dennison Belgie Bvba · Nov 5, 2015
K163529 — ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) · Avery Dennison Corporation · Mar 29, 2017
K153410 — 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing · 3M Company · May 15, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200641 Device Name HaloGUARD™ Protective Disc with CHG ## Indications for Use (Describe) 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. | 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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ ### 5 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. ### 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 Device HaloGUARD™ Protective Disc with CHG K200641 | Predicate Device BIOPATCH Protective Disk with CHG K003229 | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Product Code | FRO | FRO | | 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. | BIOPATCH containing Chlorhexidine Gluconate is intended for use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non- vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheters, drains, chest tubes, externally placed orthopedic pins, and epidural catheters. It is also intended to reduce local infections, catheter-related blood stream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters. | | Single Use | Yes | Yes | | Disposable | Yes | Yes | | Material | Medical grade foam impregnated with CHG with a film backing with print | Medical grade foam impregnated with CHG with a film backing with print | | Antibacterial Agent | Chlorhexidine gluconate (CHG) | Chlorhexidine gluconate (CHG) | | Sterilization Method | E-beam Radiation | Ethylene Oxide | | Sterility Assurance Level (SAL) | 10-6 | 10-6 | # Table 2. Summary Comparison of Characteristics {5}------------------------------------------------ | Characteristic | Subject Device HaloGUARD™ Protective Disc with CHG K200641 | Predicate Device BIOPATCH Protective Disk with CHG 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 {6}------------------------------------------------ ### 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.