· PICC Convenience Kit with Xcela® Hybrid with PASV® Valve Technology: for short or long-term peripheral access to the central venous system for intravenous therapy. including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.
· PICC Convenience Kit with NMI PICC II; or with NMI PICC; or with BSC PICC: for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

· PICC Convenience Kit with Vaxcel® PICC with PASV® Valve Technology: for use in establishing peripheral access to the central venous system for administration of fluids including, but nor limited to hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.

Device Description

The PICC Convenience Kit includes packaging configurations that will accommodate a specified NMI PICC and other legally marketed procedural aides typically used during clinical placement.

AI/ML Overview

This is a 510(k) summary for a medical device called the "PICC Convenience Kit." It is not a study that proves the device meets specific acceptance criteria in the way a clinical study for an AI algorithm would. Instead, it demonstrates substantial equivalence to predicate devices based on regulatory compliance and standard testing.

Here's an analysis of the provided text in the context of your request:

Acceptance Criteria and Reported Device Performance

The "PICC Convenience Kit" is a collection of existing, legally marketed components (PICC catheters and procedural aides) bundled for convenience. The "performance" described here relates to its packaging and sterilization, not to a new功能 of the PICC catheter itself that would require clinical performance metrics like sensitivity or specificity.

Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Packaging Integrity	Must meet national/international standards for medical device packaging to ensure sterility and integrity (AAMI/ANSI/ISO 11601-1, 11601-2).	"Successful results" of Packaging Standards Testing demonstrated that the proposed kits met pre-determined acceptance criteria applicable to safe use.
Sterilization Efficacy	Must achieve and maintain sterility, with residuals within acceptable limits, per recognized standards (AAMI/ANSI/ISO Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals).	"Successful results" of EO Sterilization Testing demonstrated that the proposed kits met pre-determined acceptance criteria applicable to safe use.
Substantial Equivalence	The modified device (the kit configuration and packaging) must be as safe and effective as legally marketed predicate devices, and not raise new questions of safety or effectiveness, as assessed by FDA's 510(k) Decision Making Tree and guidance for convenience kits.	Determined to be substantially equivalent to predicate NMI PICCs based on testing results and consideration of FDA guidance.
PICC Performance	Maintain the established performance characteristics (e.g., flow rate for power injection, suitability for fluid administration, blood sampling, central venous pressure monitoring) of the included predicate PICC catheters (e.g., Xcela® Hybrid, NMI PICC II, Vaxcel® PICC). These are not re-evaluated for the kit; their individual clearances cover these performance aspects.	The kit includes existing PICCs with their previously cleared performance characteristics (e.g., Xcela Hybrid PICC with PASV Valve Technology has a maximum power injection flow rate of 6 mL/sec). These aspects are not new or remeasured for the kit itself.

Study Information (as applicable to a 510(k) for a Convenience Kit)

This document describes a regulatory submission (510(k)), not a clinical trial or a study of an AI algorithm. Therefore, many of your requested points are not applicable.

Sample size used for the test set and the data provenance:
- Not Applicable in the context of an AI algorithm's test set. The "testing" here refers to packaging and sterilization validation. The document does not specify sample sizes for these tests, which would typically be determined by relevant ISO standards and internal validation protocols for manufacturing and quality control.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective for these specific validation tests. However, the standards cited are international.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. There is no "ground truth" in the sense of expert annotation for image analysis or clinical diagnosis. The "ground truth" for packaging and sterilization is defined by the technical specifications of the standards (e.g., a package must maintain sterility, ethylene oxide residuals must be below a certain threshold).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept relates to expert consensus in interpreting ambiguous data (e.g., medical images). The testing described here involves physical and chemical property measurements against pre-defined thresholds.
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, not done. This device is a physical medical kit, not an AI algorithm. Therefore, an MRMC study is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not done. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Technical Specifications/Standard Compliance: The "ground truth" for the packaging and sterilization tests is regulatory compliance and adherence to established international and national standards (e.g., ISO, AAMI, FDA guidance documents). For example, if a package must maintain sterility for five years, the "ground truth" is that it either does or does not, as determined by accelerated aging and bacterial ingress tests.
The sample size for the training set:
- Not Applicable. This is not an AI algorithm, so there is no training set. The "training" in the context of medical devices relates to manufacturing processes and personnel, not machine learning.
How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, there is no ground truth establishment for one.

In summary, this 510(k) submission for a "PICC Convenience Kit" focuses on demonstrating substantial equivalence to already cleared predicate devices by showing that the new packaging configuration meets mandated safety and performance standards for sterilization and packaging integrity. It is not a clinical study of a novel device or an AI application with corresponding performance metrics like accuracy, sensitivity, or specificity.

Summary

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K121990

3 2012 AUG

26 Forest Street Marlborough, MA D1752 Tel 508.658.7990

ww.navilyslmedical.com

Date prepared: 5 July 2012

510(k) Summary for the PICC Convenience Kit

Sponsor

Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752

B. Contact

Marion W. Gordon Sr. Manager Global Regulatory Affairs Phone: 508-658-7942

C. Device Name

Trade Name: Common/Usual name: Classification Name:

Classification Panel:

D. Predicate Device

Trade Name: Common/Usual name: Classification Name:

Premarket Notification

or

Lorraine M. Hanley Vice President Global Regulatory Affairs Phone: 508-494-1129

PICC Convenience Kit

Catheter, Intravascular Therapeutic, short and longterm greater than 30 days 21 CFR §880.5970, Class Il General Hospital Device Panel

PICC Convenience Kit

Peripherally Inserted Central Catheter (PICC) Catheter, Intravascular Therapeutic, short and longterm greater than 30 days 21 CFR §880.5970, Class II K111906, K101326, K093366, K091261, K070002, K021704

E. Device Description

The PICC Convenience Kit includes packaging configurations that will accommodate a specified NMI PICC and other legally marketed procedural aides typically used during clinical placement.

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F. Intended Uses

· PICC Convenience Kit with Xcela® Hybrid with PASV® Valve Technology:

for short or long-term peripheral access to the central venous system for intravenous therapy. including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.

· PICC Convenience Kit with NMI PICC II; or with NMI PICC; or with BSC PICC:

for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

· PICC Convenience Kit with Vaxcel® PICC with PASV® Valve Technology:
for use in establishing peripheral access to the central venous system for administration of fluids including, but nor limited to hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.

G. Summary of Similarities and Differences in Technological Characteristics and Performance

Similarities

The proposed PICC Convenience Kit contains one of the identified predicate PICCs packaged with a variety of procedural aide componentry typically used during PICC placement.

Differences

The proposed packaging configurations differ from the predicate PICC packaging in order to contain a broader selection of procedural aides used in PICC placement. All packaging is manufactured from packaging materials that are well characterized and commonly used in the medical industry.

H. Performance

No performance standards have been established under section 514 of the Food, Drug and Cosmetic Act for these devices. The performance evaluation of the PICC Convenience Kit was conducted based upon a risk analysis and included testing conducted in accordance with the following national/international standards and FDA guidance documents:

AAMI/ANSI/ISO Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization . residuals (2008)
A AMI/ANSI/ISO 11601-1 Packaging for terminally sterilized medical devices-Part 1: . Requirements for materials, sterile barrier systems, and packaging systems (2006)
A AMI/ANSI/ISO 11601-2 Packaging for terminally sterilized medical devices Part 2: Validation t requirements for forming, sealing and assembly processes (2006)
FDA's Convenience Kits, Interim Regulatory Guidance: 20 May 1997 .
FDA's Sterilized Convenience Kits for Clinical and Surgical Use: 7 January 2002 .

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Safety and Performance Testing I.

The successful results of the following key tests demonstrate that the proposed NMI PICC Convenience Kits have met the pre-determined acceptance criteria applicable to the safe use of the devices.

Tests:

Packaging Standards Testing
EO Sterilization Testing

J. Conclusion

Results of testing according to recognized standards and in consideration to the responses posed in FDA's Guidance on the CDRH Premarket Notification Review Program, 510(k) Decision Making Tree, the proposed PICC Convenience Kit is determined to be substantially equivalent to the predicate NMI PICCs.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

3 2012 AUG

Ms. Marion W. Gordon Senior Manager, Global Regulatory Affairs Navilyst Medical Incorporated 26 Forest Street Marlborough, Massachusetts 01752

Re: K121990

Trade/Device Name: PICC Convenience Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 5, 2012 Received: July 6, 2012

Dear Ms. Gordon:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if Known):

Device Name:

PICC Convenience Kit

with

Xcela® Hybrid PICC with PASV® Valve Technology

Indications for Use:

for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.

Prescription Use (21 CFR 801 Subpart D) × And/Or

AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rld C. Olyn 8/2/12
(Division Sign-Off)

Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: 990

4-2

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Indications for Use

510(k) Number (if Known):

Device Name:

PICC Convenience Kit with ́ NMI PICC II Or with NMI PICC Or with BSC PICC

Indications for Use:

Prescription Use (21 CFR 801 Subpart D) And/Or

ಹ

AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rld C. Chyn 8/2/12
(Division Sign-Off)

Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: K121990

{7}------------------------------------------------

Indications for Use

510(k) Number (if Known):

Device Name:

PICC Convenience Kit

Vaxcel® PICC with PASV® Valve Technology with

Indications for Use:

for use in establishing peripheral access to the central venous system for administration of fluids including, but nor limited to hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.

Prescription Use (21 CFR 801 Subpart D) ಸಿ And/Or AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rell C. 8/2/12

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Denta. Devices

510(k) Number: K121998

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.”