The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of power injectors used with the pressure injectable PICC catheter may not exceed 300 psi. The maximum pressure injection flow rate ranges from 4 ml/sec to 6 ml/sec. Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a Blue Bullseye, the catheter tip is in the desired location.

The VPS System is indicated for use as alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady Blue Bullseye is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

Device Description

The Arrow PICC powered by Arrow VPS Stylet has the following characteristics:

. 4 Fr, 1-Lumen, 40-55 cm catheter preloaded with VPS Stylet
5 Fr, 2-Lumen 40-55 cm catheter preloaded with VPS Stylet ●
6 Fr, 3-Lumen 40-55 cm catheter preloaded with VPS Stylet .

The Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

The Arrow Pressure Injectable PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media.

The Arrow VPS Stylet is a polyimide tube containing a Doppler sensor on a coax cable and an intravascular electrocardiogram (ivECG) signal sensing stainless steel wire. The Doppler sensor and the exposed portion of the ivECG are located at the distal end of the stylet and are used to detect and transmit physiological information to the VPS Console for analysis. The proximal end contains a connector to the VPS Console or to an extension cable that in turn connects to the VPS Console. The stylet was designed to be inserted and removed from any catheter with a luminal diameter of at least 0.021 inch. For user convenience, Arrow has created the Arrow PICC powered by Arrow VPS Stylet in which the Arrow PICC is provided pre-loaded with the Arrow VPS Stylet.

AI/ML Overview

The provided text, K121941, describes a 510(k) premarket notification for a medical device (Arrow PICC powered by Arrow VPS Stylet). It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo study with acceptance criteria and performance data for a new device's efficacy or accuracy.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a new AI/software-driven diagnostic or treatment device.

Here's why and what information is missing based on your request:

A table of acceptance criteria and the reported device performance: Not applicable. The submission is for substantial equivalence. The "performance" discussed relates to physical characteristics like tensile strength and burst pressure for the catheter and stylet, not a clinical performance metric.
Sample size used for the test set and the data provenance: Not applicable for clinical performance. The nonclinical testing mentioned (tensile strength, burst, etc.) would have its own sample sizes, but these are not provided. There's no "test set" of clinical data for AI performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established for AI performance.
Adjudication method: Not applicable. No clinical ground truth was established for AI performance.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, it was not.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, it was not. The VPS Stylet provides "real-time catheter tip location information" using physiological data, but this is a real-time guidance system, not an "algorithm only" diagnostic.
The type of ground truth used: For the "guidance and tip positioning" aspect, the VPS System uses "patient's physiological (cardiac electrical activity and blood flow) information" to indicate "desired location." The "ground truth" for confirming tip placement after using the device is still external verification (e.g., fluoroscopy or chest x-ray if a steady Blue Bullseye is not obtained). The submission claims the VPS System is an alternative method to fluoroscopy or chest x-ray when a steady Blue Bullseye is obtained. This implies that the 'Blue Bullseye' indicator is the surrogate for correct placement, but the document doesn't detail the validation of this 'Blue Bullseye' against an independent gold standard in a study context.
The sample size for the training set: Not applicable. This is not an AI algorithm trained on a dataset in the way a diagnostic AI would be.
How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

The submission K121941 is for a combination device: the "Arrow PICC powered by Arrow VPS Stylet." The core of the submission relies on demonstrating substantial equivalence to existing, already cleared devices:

K103255: Vascular Positioning System (VPS System) Stylet
K113277: Arrow ADVANTAGE Pressure Injectable Peripherally Inserted Central Catheter (PICC)
K080604: Pressure Injectable PICC

The argument is that combining these two previously cleared devices "does not raise new issues of safety or effectiveness."

Nonclinical Testing:
The document states that "Nonclinical Testing" was performed for:

Catheter performance: tensile strength, and burst tests.
Stylet performance: tensile, Hi-pot, continuity, and removal testing.

The results of these tests "demonstrate that the Arrow PICC powered by Arrow VPS Stylet is as safe, as effective and performs comparably to the predicate VPS stylet and Pressure Injectable PICC." However, specific acceptance criteria or detailed numerical results from these tests are not provided in this summary.

In conclusion, this 510(k) summary focuses on demonstrating that a combination of two already-cleared physical devices is substantially equivalent to those individual devices, without presenting new clinical performance data or acceptance criteria for a novel AI/software component as requested.

Summary

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K121941

pg 1 of 3

510(K) SUMMARY

7 2012

SEP

Submitter Information

Name:	Arrow International, Inc (subsidiary of Teleflex Inc.)
Address:	2400 Bernville RoadReading, PA 19605-9607 USA
Contact Person:	Elizabeth DuncanSr. Regulatory Affairs Specialist
Telephone Number:	(610) 378-0131 Extension 603220
Fax Number:	(610) 478-3179
Email:	elizabeth.duncan@teleflex.com
Date Prepared:	June 28, 2012

Device Name

Device Trade Name: Arrow PICC powered by Arrow VPS Stylet Common Name, Catheter: Peripherally Inserted Central Catheter (PICC) Common Name, Stylet: Catheter, Ultrasound, Intravascular

Classification Name, Catheter: Percutaneous, implanted, long-term intravascular catheter per 21 CFR: 880.5970

Classification Name, Stylet: Diagnostic Intravascular Catheter per 21 CFR 870.1200

Predicate Devices

K103255: Vascular Positioning System (VPS System) Stylet �
K 113277: ArrowADVANTAGE5 Pressure Injectable Peripherally Inserted Central . Catheter (PICC)
K080604: Pressure Injectable PICC .

Device Description

The Arrow PICC powered by Arrow VPS Stylet has the following characteristics:

. 4 Fr, 1-Lumen, 40-55 cm catheter preloaded with VPS Stylet
5 Fr, 2-Lumen 40-55 cm catheter preloaded with VPS Stylet ●
6 Fr, 3-Lumen 40-55 cm catheter preloaded with VPS Stylet .

The Arrow PICC is pre-loaded with the Arrow VPS Stylet and will be provided in sterile kit configurations.

The Arrow Pressure Injectable PICC is a short-term or long-term, single use catheter designed to provide access to the central venous system. It consists of a non-tapered, radiopaque

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K121941
p3 2 of 3

polyurethane extruded catheter body with a softer, contoured Blue Flex Tip. The catheter can be used for the injection of contrast media.

Indications for Use and Intended Use

The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for.intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of power injectors used with the pressure injectable PICC catheter may not exceed 300 psi. The maximum pressure injection flow rate ranges from 4 ml/sec to 6 ml/sec. Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection.

The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When the VPS System guidance indicator shows a blue bullseve, the catheter tip is in the desired location.

The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients when a steady blue bullseve is obtained. NOTE: If a steady Blue Bullseye is not obtained, standard hospital practice should be followed to confirm catheter tip location.

Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the Pwave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.

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Technological Characteristics and Substantial Equivalence

The Arrow PICC powered by Arrow VPS Stylet is substantially equivalent to the Vascular Positioning System (VPS System) Stylet (K103255), ArrowADVANTAGE Pressure Injectable Peripherally Inserted Central Catheter (PICC) (K113277) and the Pressure Injectable PICC (K080604) in terms of indications for use, design, manufacturing process, functional performance, and materials of construction. The subject device combines the predicate Arrow VPS Stylet and the Arrow Pressure Injectable PICCs; there is no change to the previously cleared devices or their indications for use.

Nonclinical Testing

The results of the catheter performance testing: tensile strength, and burst and the stylet performance testing: tensile, Hi-pot, Continuity and removal testing demonstrate that the Arrow PICC powered by Arrow VPS Stylet is as safe, as effective and performs comparably to the predicate VPS stylet and Pressure Injectable PICC.

Conclusions

The predicate and the subject devices have the same indications for use, intended use, design, materials, and are manufactured using the same processes. The results of the testing performed have demonstrated that combining the two previously cleared devices does not raise new issues of safety or effectiveness and therefore the combination is considered substantially equivalent to the cited predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

SEP 7 2012

Arrow International, Inc. c/o Ms. Elizabeth Duncan Sr. Regulatory Affairs Specialist 2400 Bernville Road Reading, PA 19605

Re: K121941

Trade/Device Name: Arrow PICC powered by Arrow VPS Stylet Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS, OBJ Dated: August 29, 2012 Received: August 30, 2012

Dear Ms. Duncan:

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.

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

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Page 2 - Ms. Elizabeth Duncan

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,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _

Device Name: Arrow PICC powered by Arrow VPS Stylet

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K121941

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.”