(245 days)
No
The device description and performance studies focus on mechanical function and tamper evidence, with no mention of AI or ML technologies.
No
The device is described as a "tamper evident enclosure" for catheter hubs and needleless connectors, and its function is to provide security and tamper indication for these medical devices, not to treat or diagnose a disease or condition. It acts as an accessory to medical devices, specifically PICC lines and other central line catheter ports.
No
The device is described as a tamper-evident enclosure for catheter ports, designed to prevent unauthorized access and indicate if the device has been tampered with. Its function is mechanical containment and indication of tampering, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "two-piece plastic housing" and describes its physical locking mechanism, indicating it is a hardware device.
Based on the provided information, the PICCGuard device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to serve as a tamper-evident enclosure for catheter and Luer hubs on medical devices like PICC lines. This is a physical barrier and security measure for a medical device used for administering substances into the body.
- Device Description: The description details a physical, mechanical device designed to lock onto a catheter port. It does not involve any testing of samples from the human body (in vitro).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
The PICCGuard is an accessory to a medical device (PICC lines and central line catheters) that is used in vivo (within the living body), not in vitro (in glass/outside the body). Its function is to protect the access point of the catheter, not to perform any diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PZW, LJS, FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Patients requiring a long-term central line catheter
Intended User / Care Setting
Hospitals and Clinics
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)
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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Image /page/0/Picture/0 description: The image contains 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.
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
1
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)
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.
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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21
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510(k) Summary
| Company Name: | PICCGuard LLC |
|---|---|
| Address: | P.O. Box 1235 |
| City: | Sheboygan |
| State: | WI 53082 |
| Contact Person: | Katie Justus |
| President | |
| 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 Medical | ||
| Industries, Inc. | Tamper Evident Cap with Male | ||
| Luer Lock | K182545 |
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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.
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 | Substantially |
| Equivalent | |||
| Classification Name | Percutaneous, | ||
| implanted, long- | |||
| term intravascular | |||
| catheter | Percutaneous, | ||
| implanted, long- | |||
| term intravascular | |||
| catheter | Substantially | ||
| Equivalent | |||
| Product Code | PZW, LJS, FPA | LJS | Different |
| Review Panel Division | General Hospital | General Hospital | Substantially |
| Equivalent | |||
| Intended 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 | The catheters are | ||
| intended for short | |||
| or long term | |||
| peripheral access | |||
| to the central | |||
| venous system for | |||
| intravenous | |||
| therapy and blood | Different | ||
| See Technological | |||
| Characteristics |
PREDICATE PRODUCT COMPARISON TABLE (Primary)
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| PICCGuard | Vygon | Comments | |
|---|---|---|---|
| on medical devices | sampling. | ||
| such as PICC lines | |||
| and other central line | |||
| catheter ports. | |||
| Use Environment | Hospitals and Clinics | Hospitals and Clinics | Substantially |
| Equivalent | |||
| Patient Population | Patients requiring a | ||
| long-term central line | |||
| catheter | Patients requiring a | ||
| long-term central line | |||
| catheter | Substantially | ||
| Equivalent |
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 edition | ||
| 2009-06-01 | Biological evaluation of | |
| medical devices - Part 5: | ||
| Tests for in vitro cytotoxicity | ||
| (Fluid Extraction/L929 Mouse | ||
| Fibroblast) | Under the conditions of this | |
| study, the Test Article meets | ||
| test acceptance criteria | ||
| 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) | Under the conditions of this | |
| study, the test article is a Non- | ||
| sensitizer. | ||
| ANSI AAMI ISO 10993- | ||
| 10:2010/(R)2014 | Biological evaluation of | |
| medical devices - Part 10: | ||
| Tests for irritation and skin | ||
| sensitization (Cottonseed Oil) | Under the conditions of this | |
| study, the test article is a Non- | ||
| sensitizer. | ||
| ANSI AAMI ISO 10993- | ||
| 10:2010/(R)2014 | Biological evaluation of | |
| medical devices - Part 10: | Under the conditions of this | |
| study. The Test Article Passes |
Biocompatibility Tests Summary and of Results
7
| Standard Number | Description | Conclusion |
|---|---|---|
| Tests for irritation and skin | ||
| sensitization (0.9% NaCl and | ||
| CSO Extracts) |
Functional Testing Results Summary Table
| Test | Acceptance Criteria | 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 | ||
| Repeated Removal of | ||
| PICCGuard from PICC lines | The catheter shows no sign of leakage after | |
| assemble / disassemble / flush cycles. | All samples | |
| Passed | ||
| Removable of Wings by | ||
| Medical Scissors | The tabs of the device shall easily be cut by | |
| medical scissors | All samples | |
| Passed |
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