Who is the manufacturer of Progreat Lambda?

Terumo Clinical Supply Co., Ltd. filed the 510(k) submission for Progreat Lambda (K211078).

What is the FDA product code for Progreat Lambda?

DQO. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Progreat Lambda?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Progreat Lambda?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Progreat Lambda

K211078 · Terumo Clinical Supply Co., Ltd. · DQO · Dec 21, 2021 · Cardiovascular

Device Facts

Record ID	K211078
Device Name	Progreat Lambda
Applicant	Terumo Clinical Supply Co., Ltd.
Product Code	DQO · Cardiovascular
Decision Date	Dec 21, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1200
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Progreat Lambda is a single-use microcatheter system for peripheral vascular interventions. It functions as a conduit for delivering contrast media, embolic materials, or drugs. The device consists of a multi-layer polymer tube reinforced with a tungsten wire mesh, featuring a PTFE inner layer for guidewire compatibility and a hydrophilic outer coating for lubricity. It is operated manually by a physician in a clinical setting. The device is inserted into the peripheral vasculature to reach target sites; the physician monitors placement and performs infusions through the catheter hub. The output is the targeted delivery of therapeutic or diagnostic agents, which facilitates procedures like embolization or intra-arterial therapy. The device benefits patients by enabling minimally invasive access to peripheral vessels for localized treatment.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including radio-detectability, tensile force, leakage, power injection, particulate evaluation, coating integrity, torque strength, flexibility/kink resistance, and simulated use. Biocompatibility testing was performed per ISO 10993-1.

Technological Characteristics

Multi-layer polymer tubing with embedded tungsten reinforcement wire; PTFE inner layer; hydrophilic coating (Dimethyl acrylamide-glycidyl methacrylate copolymer); Pt-Ir radiopaque marker; Polyamide/Silicone hub. Dimensions: 1.7Fr and 1.9Fr; 110-175cm lengths. Manual operation. Ethylene oxide sterilization (ISO 11135:2014).

Indications for Use

Indicated for infusion of contrast media, embolic materials for hemostasis, or drugs in peripheral vasculature. Contraindicated for use in cerebral or coronary vessels.

Regulatory Classification

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.

Predicate Devices

PROGREAT (K033583)

Reference Devices

Merit Pursue Microcatheter (K173548)
TRUSELECT Microcatheter (K201792)

Related Devices

K062126 — EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 · Biosphere Medical, Inc. · Aug 9, 2006
K170223 — Progreat · Ashitaka Factory of Terumo Corporation · Jul 21, 2017
K173430 — SeQure® NF and SeQure® Microcatheters · Accurate Medical Therapeutics, Ltd. · Jan 26, 2018
K210808 — Instylla Microcatheter 1.2 · Instylla, Inc. · Apr 15, 2021
K192625 — PG Pro Microcatheter · MicroVention, Inc. A TERUMO Group Company · Nov 21, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |----------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 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 {4}------------------------------------------------ Image /page/4/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, block letters. The swoosh is positioned above and to the left of the company name. ### 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: 1. K033583: PROGREAT, manufactured by Ashitaka Factory of Terumo Corporation Reference Devices: - 1. K173548: Merit Pursue Microcatheter, Merit Medical Systems, Inc. - 2. 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, sans-serif font. The swoosh is curved and positioned above the left side of the word. ## 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. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The font is sans-serif and bolded. #### 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. {8}------------------------------------------------ | | 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 *: blood contacting material | Information not publicly available. | Information not publicly available. | | Device Characteristic | Subject Device: | Predicate Device: | Reference Device #1: | Reference Device #2: | | | Progreat Lambda | Progreat | Merit Pursue Microcatheter | TRUSELECTTM Microcatheter | | | | K033583 | K173548 | K201792 | | Package | • Individual package on which the product label and the peel-off labels are attached • 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.:0.57/0.94mm 1.9Fr./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 | PROGREAT K033583 | Merit Pursue Microcatheter K173548 | TRUSELECT™ Microcatheter K201792 | | Specifications | • I.D. 1.7Fr.: 0.43mm 1.9Fr.: 0.48mm • Maximum Guide Wire outer diameter: 0.016" | • I.D. 2.0Fr.:0.019"/0.49mm 2.4Fr.:0.022"/0.57mm 2.7Fr.:0.025"/0.65mm 2.8Fr.:0.027"/0.70mm • Maximum Guide Wire outer 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 guidewire outer diameter: 1.7Fr.type: 0.014" 2.0Fr.type: 0.018" | • I.D. 0.021"(0.53mm) • Maximum guidewire outer diameter: 0.016" or 0.014" | | Specifications | • Distal tip shape: Straight/Angle/Triple angle • Maximum injection pressure: 900 psi | • Distal tip shape: straight/angled • Maximum injection pressure: 2.0Fr. : 750psi 2.4, 2.7Fr.: 750psi 2.8Fr. : 900 psi | • Distal tip shape: straight/angled • Maximum injection pressure: 800 psi | • Distal tip shape: straight/angled(Bern- shape) • Maximum injection pressure: 800 psi | | Sterilization | Ethylene oxide | Same | Same | Same | | Shelf life | 2 years | 2 years | Information not publicly available. | Information not publicly available. | # Table 5.4: Summary of Comparative Information {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ #### 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. {13}------------------------------------------------ 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. {14}------------------------------------------------ # 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.