Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical catheter device and its mechanical properties, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as an infusion catheter used for drug infusion in intra-arterial therapy, which falls under therapeutic indications.

Diagnostic

No

Explanation: The device is a catheter designed for the infusion of contrast media, embolic materials, or drugs, and its description focuses on its physical properties for material delivery, not for acquiring diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly states that Progreat Lambda is a physical catheter made of metal wire mesh reinforced multi-layer polymer tubing, designed for infusion. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for the infusion of substances (contrast media, embolic materials, drugs) into the peripheral vasculature. This is a therapeutic or diagnostic procedure performed in vivo (within the living body).
Device Description: The description details a catheter designed for insertion into blood vessels. This is a medical device used for direct intervention within the body.
Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. The provided information does not mention any such use or interaction with patient specimens outside the body.

Therefore, Progreat Lambda is a medical device used for interventional procedures, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Progreat Lambda is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intra-arterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels.

Product codes (comma separated list FDA assigned to the subject device)

DQO, KRA

Device Description

Progreat Lambda is a single use, ethylene oxide sterilized device that is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intra-arterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels.

The catheter consists of metal wire mesh reinforced multi-layer polymer tubing. The mesh is embedded in the catheter wall the entire length of the catheter with the exception of the distal tip section. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire.

The outer surface of the catheter is coated with a hydrophilic polymer with the exception of the proximal end that is 60cm from the catheter hub. The coating becomes lubricious when wet with saline solution or blood.

The device is offered in effective lengths of 110, 130, 150, 165 and 175 cm. French size and shaft outer and inner diameter are given in Table 5.1.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature, excluding the blood vessels belonging to the central circulatory system.

Indicated Patient Age Range

Not Found

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)

Performance testing was conducted to ensure the safety and effectiveness of Progreat Lambda throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. With the exception of the Radio-detectability1 test and Embolic device compatibility for coil and microsphere2, the following performance tests were performed on non-aged and accelerated aged samples.

Test Items: Radio-detectability, Surface, Peak tensile force, Freedom from leakage, Fluid leakage (Hub), Sub-atmospheric pressure air leakage (Hub), Stress cracking (Hub), Resistance to separation from axial load (Hub), Resistance to separation from unscrewing (Hub), Resistance to overriding (Hub), Power injection, Distal tip, Particulate evaluation, Coating integrity, Torque strength, Distal marker strength, Product dimension, Embolic device compatibility, Flexibility and kink test, Wire compatibility, Simulated Use.

Results: Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.

Biocompatibility: Performed in accordance with ISO 10993-1, device classified as Externally Communicating Device, Circulating Blood, Limited Contact (

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).

Summary

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December 21, 2021

Terumo Clinical Supply Co., Ltd. c/o Vaibhav Sivaramakrishan, Terumo Medical Corporation Regulatory Affairs Specialist II 265 Davidson Ave., Suite 320 Somerset, New Jersey 08873

Re: K211078

Trade/Device Name: Progreat Lambda Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, KRA Dated: November 30, 2021 Received: December 1, 2021

Dear Vaibhav Sivaramakrishan:

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

1

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 (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,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K211078

Device Name Progreat Lambda

Indications for Use (Describe)

Progreat Lambda is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intra-arterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels.

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 K211078

A. SUBMITTER INFORMATION (807.92(a)(1))

| Prepared by: | Vaibhav Sivaramakrishan
Sr. Regulatory Affairs Specialist
Terumo Medical Corporation
Phone#: (609) 613-3958
Fax#: (410) 398-6079 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared for: | Owner/Operator
TERUMO CLINICAL SUPPLY CO., LTD.
3, Kawashima-Takehayamachi, Kakamigahara,
Gifu, Japan, 501-6024
Owner/Operator Number: 100 396 57
Manufacturer and Sterilization Facility (Applicant)
TERUMO CLINICAL SUPPLY CO., LTD.
3, Kawashima-Takehayamachi, Kakamigahara,
Gifu, Japan, 501-6024
Registration Number: 3009500972 |
| Contact Person: | Vaibhav Sivaramakrishan
Sr. Regulatory Affairs Specialist
Terumo Medical Corporation
265 Davidson Avenue, Suite 320
Somerset, NJ 08873
Phone#: (609) 613-3958
Fax#: (410) 398-6079
Email: vai.sivaramakrishan@terumomedical.com |

Date prepared: December 21, 2021

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B. DEVICE NAME (807.92(a)(2))

Proprietary Name:	Progreat Lambda
Common Name:	Micro Catheter System
Classification Name:	Diagnostic Intravascular Catheter (DQO)
	Continuous flush catheter (KRA)
Classification Panel:	Cardiovascular
Regulation:	21 CFR 870.1200
Product Code:	DQO, KRA
Classification:	Class II

C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed device to which substantial equivalence is claimed is:

Primary Predicate Device:

K033583: PROGREAT, manufactured by Ashitaka Factory of Terumo Corporation

Reference Devices:

1. K173548: Merit Pursue Microcatheter, Merit Medical Systems, Inc.
1. K201792: TRUSELECT Microcatheter, Boston Scientific Corp.

D. REASON FOR 510(k) SUBMISSION

This Traditional 510(k) is being submitted for Progreat Lambda for the purposes of establishing substantial equivalence to a legally marketed predicate device.

E. DEVICE DESCRIPTION (807.92(a)(4))

Principle of Operation Technology

Progreat Lambda submitted in this 510(k) and its predicate Progreat (K033583) are operated by a manual process.

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Design/Construction

Progreat Lambda is a single use, ethylene oxide sterilized device that is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intra-arterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels.

The catheter consists of metal wire mesh reinforced multi-layer polymer tubing. The mesh is embedded in the catheter wall the entire length of the catheter with the exception of the distal tip section. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire.

The outer surface of the catheter is coated with a hydrophilic polymer with the exception of the proximal end that is 60cm from the catheter hub. The coating becomes lubricious when wet with saline solution or blood.

The device is offered in effective lengths of 110, 130, 150, 165 and 175 cm. French size and shaft outer and inner diameter are given in Table 5.1.

French Size	Shaft Outer Diameter (mm)		Shaft Inner Diameter (mm)
	Distal part	Proximal part	Distal part	Proximal part
1.7 Fr.	0.57	0.94	0.43	0.58
1.9 Fr.	0.64	0.94	0.48	0.60

Table 5.1: Catheter size

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Materials

The materials for Progreat Lambda are provided in Table 5.2.

No.	Name of Component			Raw material
1*	Shaft	Outer layer		Polyester Elastomer
			Pigment
2	Shaft	Reinforcement wire		Tungsten
3*	Catheter	Inner layer		Polytetrafluoroethylene
4*		Distal tip section	Outer layer	Polyester Elastomer
				Pigment
5*	Distal tip section	Inner layer		Polytetrafluoroethylene

6	Radiopaque marker			Pt-Ir alloy
7*	Hydrophilic polymer coating			Dimethyl acrylamide - glycidyl
methacrylate copolymer
8	Quick-drying glue			Cyanoacrylate
9*	Catheter hub			Polyamide
				Silicone
10	Catheter strain relief tube			Polyester elastomer
				Pigment

Table 5.2: List of Materials

*Blood contacting material.

Specifications

The specifications for Progreat Lambda are provided in Table 5.3.

French Size		1.7 Fr.	1.9 Fr.
Catheter I.D. (mm)	Distal	0.43	0.48
	Proximal	0.58	0.60
Catheter O.D. (mm)	Distal	0.57	0.64
	proximal	0.94	0.94
Effective length (cm)*		110, 130, 150, 165, 175
Coating length(cm)		50, 70, 90, 105, 115
Maximum guidewire outer diameter		0.016"

Table 5.3: Progreat Lambda Specifications

*The length from the proximal catheter strain relief tube to the catheter distal tip.

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F. INDICATIONS FOR USE (807.92(a)(5))

Progreat Lambda is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intraarterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels.

The indications for use are equivalent to the predicate (K033583).

G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

Progreat Lambda, the subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate, K033583 -Progreat, manufactured by Ashitaka Factory of Terumo Corporation.

In addition to the above-listed primary predicate, TERUMO CLINICAL SUPPLY CO., LTD. has identified the following reference devices. These are market leading devices with the same intended use and basic design as the subject device. Because these devices are frequently used in clinical practice, TERUMO CLINICAL SUPPLY CO., LTD. felt it was appropriate to use them as references when setting the acceptance criteria for Progreat Lambda performance testing.

1. Merit Medical Systems, Inc. Merit Pursue Microcatheter (K173548)
Boston Scientific Corp.: TRUSELECT Microcatheter (K201792) 2.

A comparison of the technological characteristics is summarized in Table 5.4.

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	Subject Device:	Predicate Device:	Reference Device #1:	Reference Device #2:
Device
Characteristic	Progreat Lambda	Progreat	Merit Pursue
Microcatheter	TRUSELECT™
Microcatheter
		K033583	K173548	K201792
Manufacturer	TERUMO CLINICAL
SUPPLY CO., LTD.	Ashitaka Factory of
Terumo Corporation	Merit Medical Systems,
Inc.	Boston Scientific
Corporation
Intended Use
/Indications for Use	Progreat Lambda is
intended for the infusion
of contrast media, or
embolic materials for
hemostasis, into the
peripheral vasculature,
excluding the blood
vessels belonging to the
central circulatory
system. Progreat Lambda
is also indicated for drug
infusion in intra-arterial
therapy in the peripheral
vasculature. Progreat
Lambda should not be
used in cerebral or
coronary vessels.	Progreat is intended for
the infusion of contrast
media into all peripheral
vessels up to and
including the cervical
vessels, all vessels in the
lower and upper
extremities, and all
coronary vessels. Progreat
is also intended for drug
infusion in intra-arterial
therapy and the infusion
of embolic materials for
hemostasis. Progreat
should not be used in
cerebral vessels.	The Microcatheter is
intended for general
intravascular use,
including peripheral and
coronary vasculature.
Once the subselective
region has been accessed,
the Microcatheter can be
used for the controlled
and selective infusion of
diagnostic, embolic, or
therapeutic materials into
vessels. The catheter
should not be used in the
cerebral vessels.	The TRUSELECT™
Microcatheters are
intended for peripheral
vascular use. The
microcatheter can be used
for selective infusion of
diagnostic, embolic, or
therapeutic materials into
the vessel.
Operation Principle	Manual	Same	Same	Same
Device Characteristic	Subject Device:
Progreat Lambda	Predicate Device:
Progreat
K033583	Reference Device #1:
Merit Pursue Microcatheter
K173548	Reference Device #2:
TRUSELECT™ Microcatheter
K201792
Design/Construction	The catheter consists of inner layer, reinforcement wire, outer layer, radiopaque marker, hydrophilic polymer coating, catheter hub and catheter strain relief tube.	Same	Same	Same
Materials	Outer tube*: Polyester Elastomer

Inner tube*: PTFE

Reinforcement wire: Tungsten

Radiopaque marker: Pt-Ir alloy

Coating*: Dimethyl acrylamide glycidyl methacrylate copolymer, Silicone

Catheter hub*: Polyamide, Silicone

Catheter strain relief tube: Polyester elastomer

: blood contacting material | Outer layer: Polyester elastomer (distal) and Polyurethane elastomer (proximal)

Inner layer*:
Polytetrafluoroethylene

Reinforcing coil: Tungsten

Radiopaque maker: Pt-Ir alloy

Hydrophilic coating*:
Dimethyl acrylamide – glycidyl methacrylate – copolymer

Hub*: Nylon

Anti-kink protector: Nylon elastomer

Table 5.4: Summary of Comparative Information

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10

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H. NON CLINICAL TESTS (807.92(b)(1))

Performance Testing

Performance testing was conducted to ensure the safety and effectiveness of Progreat Lambda throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device. With the exception of the Radio-detectability1 test and Embolic device compatibility for coil and microsphere2, the following performance tests were performed on nonaged and accelerated aged samples. Table 5.5 provides a list of performance tests that were performed on Progreat Lambda.

Test Item
Radio-detectability
Surface
Peak tensile force
Freedom from leakage
Fluid leakage (Hub)
Sub-atmospheric pressure air leakage (Hub)
Stress cracking (Hub)
Resistance to separation from axial load (Hub)
Resistance to separation from unscrewing (Hub)
Resistance to overriding (Hub)
Power injection
Distal tip
Particulate evaluation
Coating integrity
Torque strength
Distal marker strength
Product dimension
Embolic device compatibility
Flexibility and kink test
Wire compatibility
Simulated Use

1 Only non-aged sample was tested since the amount of metallic material contained in the product would not change over time.

2 Only non-aged sample was tested since the inner diameter would not changed over time.

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Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.

Biocompatibility

In accordance with ISO 10993-1, Progreat Lambda is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (