(253 days)
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 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.
Here's an analysis of the acceptance criteria and supporting studies for the "Progreat Lambda" device based on the provided FDA 510(k) summary:
The document does not contain information relevant to AI/ML or a multi-reader multi-case (MRMC) study. The device described is a microcatheter, a physical medical device, not a diagnostic software or AI/ML algorithm. Therefore, many of the requested categories like effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, and training set information are not applicable to this submission.
The acceptance criteria and studies focus on the physical and biological performance of the catheter itself.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
The document states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed. Without the specific numerical thresholds for "acceptance criteria," a direct comparative table with reported performance cannot be fully constructed from this document.
Below is a table summarizing the types of performance tests conducted, implying that the device met the unstated acceptance criteria for each.
| Test Item | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Radio-detectability | Device is detectable as required. | Met predetermined acceptance criteria. |
| Surface | Surface characteristics meet specified standards (e.g., smoothness, freedom from defects). | Met predetermined acceptance criteria. |
| Peak tensile force | Withstands specified tensile forces without failure. | Met predetermined acceptance criteria. |
| Freedom from leakage | No leakage occurs under specified conditions. | Met predetermined acceptance criteria. |
| Fluid leakage (Hub) | Hub does not leak fluid under specified pressure. | Met predetermined acceptance criteria. |
| Sub-atmospheric pressure air leakage (Hub) | Hub does not leak air under specified negative pressure. | Met predetermined acceptance criteria. |
| Stress cracking (Hub) | Hub maintains integrity without cracking under stress. | Met predetermined acceptance criteria. |
| Resistance to separation from axial load (Hub) | Hub remains securely attached under specified axial load. | Met predetermined acceptance criteria. |
| Resistance to separation from unscrewing (Hub) | Hub remains securely attached despite unscrewing attempts. | Met predetermined acceptance criteria. |
| Resistance to overriding (Hub) | Hub maintains proper connection without overriding. | Met predetermined acceptance criteria. |
| Power injection | Catheter withstands specified power injection pressures. | Met predetermined acceptance criteria. |
| Distal tip | Distal tip performance meets specified criteria (e.g., flexibility, shape retention). | Met predetermined acceptance criteria. |
| Particulate evaluation | Device is free from unacceptable levels of particulates. | Met predetermined acceptance criteria. |
| Coating integrity | Hydrophilic coating remains intact and functional. | Met predetermined acceptance criteria. |
| Torque strength | Catheter withstands specified torque without damage or failure. | Met predetermined acceptance criteria. |
| Distal marker strength | Distal marker remains securely attached and detectable. | Met predetermined acceptance criteria. |
| Product dimension | Dimensions conform to specifications. | Met predetermined acceptance criteria. |
| Embolic device compatibility | Compatible with specified embolic devices for intended use. | Met predetermined acceptance criteria. |
| Flexibility and kink test | Catheter maintains flexibility and resists kinking under specified conditions. | Met predetermined acceptance criteria. |
| Wire compatibility | Compatible with specified guidewires. | Met predetermined acceptance criteria. |
| Simulated Use | Performance under simulated clinical conditions meets requirements. | Met predetermined acceptance criteria. |
| Biocompatibility (various tests listed below) | Meets ISO 10993 standards for biological safety. | Found to be biocompatible throughout the shelf life. |
| Sterilization (Ethylene Oxide) | Achieves Sterility Assurance Level (SAL) of 10-6. | Confirmed SAL of 10-6 in accordance with ISO 11135:2014. |
2. Sample size used for the test set and the data provenance
- Performance Testing: The document does not explicitly state the numerical sample size for each performance test. It mentions that tests were performed on "nonaged and accelerated aged samples," indicating multiple samples were used for each condition. The provenance of the data is internal to the manufacturer (Terumo Clinical Supply Co., Ltd., Japan). The tests are presumably prospective laboratory tests conducted on manufactured device units.
- Biocompatibility Testing: The specific numerical sample size is not provided, but it notes tests were conducted on "non-aged, sterile, whole device" and "accelerated-aged (3 years), sterile, whole device." These tests were also prospective laboratory tests.
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 medical device, not an AI/ML diagnostic. Ground truth as typically defined for AI/ML (e.g., expert consensus on medical images) does not apply. The "ground truth" for this device's performance is established by objective engineering and biocompatibility standards.
4. Adjudication method for the test set
Not applicable. This is not a diagnostic device requiring human reader adjudication. Performance is assessed against predefined engineering and biological criteria.
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 a physical medical device (microcatheter), not an AI/ML diagnostic system. Therefore, MRMC studies and AI assistance effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device. The concept of an "algorithm only" performance is not applicable.
7. The type of ground truth used
The "ground truth" for evaluating this device's performance is based on established engineering standards and specifications (e.g., tensile strength, leak rates, dimensions, coating integrity), and biocompatibility standards (ISO 10993-1, pyrogenicity, hemolysis, cytotoxicity, etc.). These are objective, measurable criteria. For manufacturing and quality, the "ground truth" is adherence to design specifications and validated processes.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. (See #8).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
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
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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
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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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Image /page/3/Picture/1 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, bold, sans-serif font. The swoosh is positioned above and to the left of the company name.
510(K) SUMMARY K211078
A. SUBMITTER INFORMATION (807.92(a)(1))
| Prepared by: | Vaibhav SivaramakrishanSr. Regulatory Affairs SpecialistTerumo Medical CorporationPhone#: (609) 613-3958Fax#: (410) 398-6079 |
|---|---|
| Prepared for: | Owner/OperatorTERUMO CLINICAL SUPPLY CO., LTD.3, Kawashima-Takehayamachi, Kakamigahara,Gifu, Japan, 501-6024Owner/Operator Number: 100 396 57Manufacturer and Sterilization Facility (Applicant)TERUMO CLINICAL SUPPLY CO., LTD.3, Kawashima-Takehayamachi, Kakamigahara,Gifu, Japan, 501-6024Registration Number: 3009500972 |
| Contact Person: | Vaibhav SivaramakrishanSr. Regulatory Affairs SpecialistTerumo Medical Corporation265 Davidson Avenue, Suite 320Somerset, NJ 08873Phone#: (609) 613-3958Fax#: (410) 398-6079Email: 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:
-
- K173548: Merit Pursue Microcatheter, Merit Medical Systems, Inc.
-
- 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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Image /page/5/Picture/1 description: The image contains the logo for Terumo. The logo features a red angled line above the word "TERUMO" which is written in a bold, green sans-serif font. The logo is simple and modern.
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 - glycidylmethacrylate 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.
-
- 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: | |
|---|---|---|---|---|
| DeviceCharacteristic | Progreat Lambda | Progreat | Merit PursueMicrocatheter | TRUSELECT™Microcatheter |
| K033583 | K173548 | K201792 | ||
| Manufacturer | TERUMO CLINICALSUPPLY CO., LTD. | Ashitaka Factory ofTerumo Corporation | Merit Medical Systems,Inc. | Boston ScientificCorporation |
| Intended Use/Indications for Use | Progreat Lambda isintended for the infusionof contrast media, orembolic materials forhemostasis, into theperipheral vasculature,excluding the bloodvessels belonging to thecentral circulatorysystem. Progreat Lambdais also indicated for druginfusion in intra-arterialtherapy in the peripheralvasculature. ProgreatLambda should not beused in cerebral orcoronary vessels. | Progreat is intended forthe infusion of contrastmedia into all peripheralvessels up to andincluding the cervicalvessels, all vessels in thelower and upperextremities, and allcoronary vessels. Progreatis also intended for druginfusion in intra-arterialtherapy and the infusionof embolic materials forhemostasis. Progreatshould not be used incerebral vessels. | The Microcatheter isintended for generalintravascular use,including peripheral andcoronary vasculature.Once the subselectiveregion has been accessed,the Microcatheter can beused for the controlledand selective infusion ofdiagnostic, embolic, ortherapeutic materials intovessels. The cathetershould not be used in thecerebral vessels. | The TRUSELECT™Microcatheters areintended for peripheralvascular use. Themicrocatheter can be usedfor selective infusion ofdiagnostic, embolic, ortherapeutic materials intothe vessel. |
| Operation Principle | Manual | Same | Same | Same |
| Device Characteristic | Subject Device:Progreat Lambda | Predicate Device:ProgreatK033583 | Reference Device #1:Merit Pursue MicrocatheterK173548 | Reference Device #2:TRUSELECT™ MicrocatheterK201792 |
| 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 ElastomerInner tube*: PTFEReinforcement wire: TungstenRadiopaque marker: Pt-Ir alloyCoating*: Dimethyl acrylamide glycidyl methacrylate copolymer, SiliconeCatheter hub*: Polyamide, SiliconeCatheter strain relief tube: Polyester elastomer*: blood contacting material | Outer layer*: Polyester elastomer (distal) and Polyurethane elastomer (proximal)Inner layer*:PolytetrafluoroethyleneReinforcing coil: TungstenRadiopaque maker: Pt-Ir alloyHydrophilic coating*:Dimethyl acrylamide – glycidyl methacrylate – copolymerHub*: NylonAnti-kink protector: Nylon elastomer*: blood contacting material | Information not publicly available. | Information not publicly available. |
| DeviceCharacteristic | Subject Device: | Predicate Device: | Reference Device #1: | Reference Device #2: |
| Progreat Lambda | Progreat | Merit PursueMicrocatheter | TRUSELECTTMMicrocatheter | |
| K033583 | K173548 | K201792 | ||
| Package | • Individual package onwhich the product label andthe peel-off labels areattached• 1 unit per package | Same | Same | Same |
| Specifications | • Effective lengths: 110,130, 150, 165, 175 cm• French size: 1.7Fr., 1.9Fr.• O.D.(Distal/Proximal)1.7Fr./2.8Fr.:0.57/0.94mm1.9Fr./2.8Fr.:0.64/0.94mm | • Effective lengths: 100,110, 130, 150 cm• French size: 2.0, 2.4, 2.7,2.8 Fr.• O.D.(Distal/Proximal)2.0Fr./2.7Fr (0.67/0.90mm)2.4/2.9Fr.(0.80/0.97mm)2.7/2.9Fr.(0.90/0.97mm)2.8/3.0Fr.(0.93/1.00mm) | • Effective Length: 110,130, 150cm• French size: 1.7Fr.,2.0Fr.• O.D.(Distal/Proximal)1.7Fr./2.8Fr.2.0Fr./2.9Fr. | • Effective Length: 105,130, 150, 175cm• French size: 2.0Fr.• O.D.(Distal/Proximal)2.0Fr./2.8Fr. |
| Device Characteristic | Subject Device: | Predicate Device: | Reference Device #1: | Reference Device #2: |
| Progreat Lambda | PROGREATK033583 | Merit PursueMicrocatheterK173548 | TRUSELECT™MicrocatheterK201792 | |
| Specifications | • I.D.1.7Fr.: 0.43mm1.9Fr.: 0.48mm• Maximum Guide Wireouter diameter: 0.016" | • I.D.2.0Fr.:0.019"/0.49mm2.4Fr.:0.022"/0.57mm2.7Fr.:0.025"/0.65mm2.8Fr.:0.027"/0.70mm• Maximum Guide Wireouter diameter:2.0Fr.type: 0.016"2.4Fr.type: 0.018"2.7Fr.type: 0.021"2.8Fr.type: 0.021" | • I.D.1.7Fr.type: 0.016"(0.40 mm)2.0Fr.type: 0.020"(0.50 mm)• Maximum guidewireouter diameter:1.7Fr.type: 0.014"2.0Fr.type: 0.018" | • I.D.0.021"(0.53mm)• Maximum guidewireouter diameter:0.016" or 0.014" |
| Specifications | • Distal tip shape:Straight/Angle/Tripleangle• Maximum injectionpressure: 900 psi | • Distal tip shape:straight/angled• Maximum injectionpressure:2.0Fr. : 750psi2.4, 2.7Fr.: 750psi2.8Fr. : 900 psi | • Distal tip shape:straight/angled• Maximum injectionpressure: 800 psi | • Distal tip shape:straight/angled(Bern-shape)• Maximum injectionpressure: 800 psi |
| Sterilization | Ethylene oxide | Same | Same | Same |
| Shelf life | 2 years | 2 years | Information not publiclyavailable. | Information not publiclyavailable. |
Table 5.4: Summary of Comparative Information
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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 (<24 hours). The finished device's patient contacting parts were tested in accordance with the tests recommended in the FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained throughout the shelf life of the product. Table 5.6 provides a list of biocompatibility tests conducted on Progreat Lambda.
| Non-aged, sterile, whole device |
|---|
| Cytotoxicity |
| Sensitization |
| Intracutaneous Reactivity |
| Acute Systemic Toxicity |
| Pyrogenicity |
| Hemolysis |
| Thrombogenicity |
| Complement Activation (Immunology) |
| Physicochemical Profile (Physicochemical and FT-IR) |
| Accelerated-aged (3 years), sterile, whole device |
| Cytotoxicity |
| Hemolysis |
| Physicochemical Profile (Physicochemical and FT-IR) |
Table 5.6: Summary of ISO 10993 Biocompatibility Testing
Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.
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Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of Health Care Products - Ethylene Oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6.
I. CLINICAL TESTS (807.92(b)(2))
This 510(k) does not include data from clinical tests.
J. CONCLUSION (807.92(b)(3))
In summary, Progreat Lambda, subject of this 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.
§ 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).