(176 days)
Not Found
No
The device is a physical disc with an antibacterial agent, and the summary describes bench and animal studies related to its physical and antimicrobial properties, with no mention of software, algorithms, or data processing.
No
The device is intended to cover insertion sites and has an antibacterial agent (CHG) to prevent infection, which is a protective rather than a therapeutic function.
No
The device is described as a "Protective Disc" intended to cover insertion sites and infused with an antibacterial agent (CHG). Its purpose is to protect and reduce infection, not to diagnose a condition.
No
The device description clearly states it is a sterile, single-use disposable disc infused with an antibacterial agent, indicating it is a physical medical device, not software.
Based on the provided information, the HaloGUARD™ Protective Disc with CHG is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover insertion sites on adult patients. This is a topical application for wound care and infection prevention at the site of medical device insertion.
- Device Description: It's a sterile, single-use disposable disc infused with an antibacterial agent. This describes a medical device for external use.
- Lack of In Vitro Testing: The performance studies mentioned are bench testing (functional requirements, antimicrobial efficacy on the device itself), animal studies (wound healing), and a statement that clinical testing was not required for substantial equivalence. There is no mention of testing biological samples (blood, urine, tissue, etc.) in vitro to diagnose or monitor a condition.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The HaloGUARD™ device does not perform this function. It is a medical device intended for external application to protect insertion sites.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Insertion sites on adult patients.
Indicated Patient Age Range
Adult patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Appearance Internal test method
- CHG Concentration Determination Internal test method
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
Clinical testing was not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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) |
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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 , FDA Recognized Standard 2-522 and USP , . FDA Recognized Standard 2-523
- Bioburden USP ●
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 ●
- 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.