The PICCGuard device is indicated for use as a tamper evident enclosure for the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports.

Device Description

The PICCGuard is a two-piece plastic housing with locking barb that inserts through a hole in the bottom housing. After inserting the shaft of the catheter and Luer hub with needleless connector attached, the two halves slide together, and the barb is pushed through the hole in the bottom housing. Once the barb is inserted, the housing is locked. When a healthcare provider needs intravenous access, medical scissors can be used to disconnect the lid from the locked portion. The PICCGuard is then removed giving access to the needleless connector, and the health care provider can administer medications per normal routine.

AI/ML Overview

The provided text is a 510(k) summary for the PICCGuard device. It describes the device, its intended use, and compares it to predicate devices. However, this document primarily discusses nonclinical performance testing related to biocompatibility and basic functional tests. It does not describe a study that proves the device meets acceptance criteria related to its primary indication as a tamper-evident enclosure in the context of improving human reader performance or a standalone algorithm performance.

Specifically, there is no mention of a device that uses an AI algorithm or requires human "readers" or experts to establish ground truth in the way described in the prompt's questions (e.g., related to image interpretation). The PICCGuard is a physical device intended to demonstrate tampering, not an AI-powered diagnostic or interpretive tool.

Therefore, many of the requested details about acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI models) are not applicable to the information provided in this 510(k) summary.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a "Functional Testing Results Summary Table" that aligns with this request for specific functional aspects of the physical device.

Test	Acceptance Criteria	Reported Device Performance	Pass/Fail
Removal of Device to Confirm Tamper Evident	The device shall show signs of being tamper with and shall break near the locking tab.	"All samples Passed" (implies all samples showed signs of tampering and broke near the locking tab)	Pass
Repeated Removal of PICCGuard from PICC lines	The catheter shows no sign of leakage after assemble / disassemble / flush cycles.	"All samples Passed" (implies no leakage was observed)	Pass
Removable of Wings by Medical Scissors	The tabs of the device shall easily be cut by medical scissors	"All samples Passed" (implies the tabs were easily cut)	Pass

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

Sample Size for Functional Tests: The document states "All samples Passed" for the functional tests. However, the number of samples tested is not explicitly stated.
Data Provenance: Not specified, but given the nature of a physical device functional test, it would likely be laboratory-based and not involve patient data or geographical provenance in the typical sense for AI/diagnostic devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This device is a physical tamper-evident enclosure, not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for its functional performance is based on direct observation of physical characteristics (breaking, no leakage, ease of cutting).

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

None. Not applicable, as there's no subjective interpretation or complex data requiring adjudication.

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:

No. This is not an AI device or a diagnostic device. No MRMC study was conducted.

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

No. This is not an algorithm.

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

For the functional tests, the "ground truth" was the direct physical demonstration of the device's characteristics:
- Tamper evidence: Visual confirmation of breaking near the locking tab.
- No leakage: Visual confirmation after assembly/disassembly/flush cycles.
- Ease of cutting: Confirmation that medical scissors can easily cut the tabs.

8. The sample size for the training set:

Not Applicable. This device is not an AI model, so there is no "training set."

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

Not Applicable. As there is no AI model or training set, this question is irrelevant.

Additional Information from the Document:

Clinical Studies: "No clinical studies were conducted."
Biocompatibility Testing: The document lists several ISO 10993 standards and provides a summary table for biocompatibility tests (cytotoxicity, irritation, skin sensitization), all concluding that the Test Article meets acceptance criteria. These are standard tests for medical devices that contact the body.
Intended Use/Indications: The device is "indicated for use as a tamper evident enclosure for the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports."
Comparison to Predicate Devices: The document focuses on comparing the PICCGuard's regulatory class, classification name, product code, review panel division, intended use, use environment, and patient population to predicate devices. The key difference highlighted is the PICCGuard's role as an accessory providing a tamper-evident feature, which is not the primary function of the direct predicate (a PICC catheter). A reference predicate (a tamper-evident cap) is mentioned for its similar tamper-evident claim.

Summary

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January 3, 2020

PICCGuard LLC % E.J. Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K191195

Trade/Device Name: PICCGuard Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: PZW, LJS, FPA Dated: December 3, 2019 Received: December 4, 2019

Dear E.J. Smith:

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

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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 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 (OS) 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,

Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K191195

Device Name PICCGuard

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

Company Name:	PICCGuard LLC
Address:	P.O. Box 1235
City:	Sheboygan
State:	WI 53082
Contact Person:	Katie JustusPresident
Phone:	918-519-2563
Email:	info@piccguard.com

Summary Preparation Date: December 11, 2019

Device Name:	PICCGuard
Common/Usual Name:	Catheter Access Cover, Tamper Resistant
Classification Name:	Catheter, Intravascular, Therapeutic, Long-Term Greater than 30-Days
Regulation Number:	21 CFR 880.5970
Primary Product Code:	PZW
Secondary Product Code:	LJS, FPA
Device Class:	Class II
Panel:	General Hospital Branch

PREDICATE DEVICE:

	Manufacturer	Brand Name	510(k) Number
Primary	Vygon	5 Fr DL PowerPICC® Catheter	K172899
Reference	International MedicalIndustries, Inc.	Tamper Evident Cap with MaleLuer Lock	K182545

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DEVICE DESCRIPTION:

INDICATIONS FOR USE

The PICCGuard device is indicated for use as a tamper evident enclosure for the shaft of the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports.

	PICCGuard	Vygon	Comments
Brand Name	PICCGuard	5 Fr DL PowerPICC®Catheter
Regulatory Class	21 CFR 880.5970	21 CFR 880.5970	SubstantiallyEquivalent
Classification Name	Percutaneous,implanted, long-term intravascularcatheter	Percutaneous,implanted, long-term intravascularcatheter	SubstantiallyEquivalent
Product Code	PZW, LJS, FPA	LJS	Different
Review Panel Division	General Hospital	General Hospital	SubstantiallyEquivalent
Intended Use	The PICCGuarddevice is indicatedfor use as a tamperevident enclosure forthe shaft of thecatheter and Luerhub with needlelessconnector attached	The catheters areintended for shortor long termperipheral accessto the centralvenous system forintravenoustherapy and blood	DifferentSee TechnologicalCharacteristics

PREDICATE PRODUCT COMPARISON TABLE (Primary)

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	PICCGuard	Vygon	Comments
	on medical devices	sampling.
	such as PICC lines
	and other central linecatheter ports.
Use Environment	Hospitals and Clinics	Hospitals and Clinics	SubstantiallyEquivalent
Patient Population	Patients requiring along-term central linecatheter	Patients requiring along-term central linecatheter	SubstantiallyEquivalent

Discussion of Differences: The PICCGuard differs from the predicate Vygon 5 Fr DL PowerPICC® in that the PICCGuard is an accessory to an intravascular catheter, and is designed to be used over the catheter to provide indication to the health care provider when unauthorized access of a catheter may have occurred by securely encasing the non-sterile Luer hub(s) placed on catheter lines. Additionally, the product code PZW reflects that the PICCGuard is an accessory to a catheter, product code LJS and FPA.

Technological Characteristics

The PICCGuard is an accessory to the predicate device and provides the predicate device with a tamper evident feature to alert the HCP of tampering.

The normal standards testing, functional testing, biocompatibility testing, sterilization and shelf-life studies of a Catheter, Intravascular, Therapeutic, Long-Term Greater than 30-Days are not applicable to the PICCGuard medical device.

PICCGuard conducted ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization and ISO 10993-10 irritation studies, which satisfy the biocompatibility requirements of ISO 10993-1 for surface device with intact skin contact and contact duration >30d.

PICCGuard successfully conducted functionality testing for the 3 key elements for PICCGuard features, 1) confirm tamper evident, 2) repeated removal a central line catheter to demonstrate no leakage for repeated assembles, and flush cycles of the centralline catheter and 3) ease-of-use using medical scissors to remove the PICCGuard . These functionality tests demonstrate the performance of the PICCGuard and raises no new issues of safety and effectiveness in use with a central line catheter.

The PICCGuard is sold non-sterile versus a central line catheter which is sold sterile. The PICCGuard does not come into direct contact with the open Luer port. The PICCGuard houses the catheter shaft and needleless connector which are considered non-sterile feature of the PICCGuard, housing the non-sterile catheter shaft and needleless connector raises no new issues of safety and effectiveness.

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In support of our indications for use statement and principle of operations the reference predicate has a similar indication for use and principle of operations of the tamper evident claim and tamper evident method. The reference predicate is also used as an accessory to a medical device used in the delivery of intravenous I.V. solutions and drugs.

NONCLINICAL PERFORMANCE TESTING

. ISO 10993-5 Third Edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (Fluid Extraction/L929 Mouse Fibroblast)
. ANSI/AAMI/ISO 10993-10:2010(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (Guinea Pig Maximization Test (0.9% NaCl)
. ANSI/AAMI/ISO 10993-10:2010(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (Cottonseed Oil)
. ANSI/AAMI/ISO 10993-10:2010(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (0.9% NaCl and CSO Extracts)
o ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices – Part 1: Evaluation and testing within a management process
. ISO 14971 Second addition 2007-03-01 Medical devices – Application of risk management to medical devices
. ISO 10555-1:2013; Intravascular catheters – sterile single-use catheters – Part 1: General requirements, Annex C (used in our functionality testing)

Standard Number	Description	Conclusion
ISO 10993-5 Third edition2009-06-01	Biological evaluation ofmedical devices - Part 5:Tests for in vitro cytotoxicity(Fluid Extraction/L929 MouseFibroblast)	Under the conditions of thisstudy, the Test Article meetstest acceptance criteria
ANSI AAMI ISO 10993-10:2010/(R)2014	Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization (Guinea PigMaximization Test (0.9%NaCl)	Under the conditions of thisstudy, the test article is a Non-sensitizer.
ANSI AAMI ISO 10993-10:2010/(R)2014	Biological evaluation ofmedical devices - Part 10:Tests for irritation and skinsensitization (Cottonseed Oil)	Under the conditions of thisstudy, the test article is a Non-sensitizer.
ANSI AAMI ISO 10993-10:2010/(R)2014	Biological evaluation ofmedical devices - Part 10:	Under the conditions of thisstudy. The Test Article Passes

Biocompatibility Tests Summary and of Results

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Standard Number	Description	Conclusion
	Tests for irritation and skinsensitization (0.9% NaCl andCSO Extracts)

Functional Testing Results Summary Table

Test	Acceptance Criteria	Pass/Fail
Removal of Device toConfirm Tamper Evident	The device shall show signs of being tamperwith and shall break near the locking tab.	All samplesPassed
Repeated Removal ofPICCGuard from PICC lines	The catheter shows no sign of leakage afterassemble / disassemble / flush cycles.	All samplesPassed
Removable of Wings byMedical Scissors	The tabs of the device shall easily be cut bymedical scissors	All samplesPassed

CLINICAL STUDIES:

No clinical studies were conducted.

CONCLUSION:

The comparative review of PICCGuard used as an accessory to a central line catheter is substantially equivalent to the predicate device

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”