(139 days)
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
The Aspiration Catheter and Tenzing 7 Delivery Catheter comprise the Route 92 Medical Full Length 070 Reperfusion System. The Route 92 Medical Full Length 070 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.
The Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 7 Delivery Catheter is a single-lumen variable stiffness catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.
The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.
For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set, along with a legally marketed canister and accessories kit.
The provided document, a 510(k) K223530 Premarket Notification for the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set, does not contain information about an AI-powered device or a study involving AI assistance for human readers. It describes a medical device (a catheter system for stroke treatment) and a series of non-clinical, benchtop, and animal studies to demonstrate its safety and effectiveness.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device's performance, as the document does not pertain to an AI device.
However, I can provide a summary of the acceptance criteria and the studies conducted for the medical device described in the document, as it meets the general structure of the request for device performance and testing.
Acceptance Criteria and Study for the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
This document describes the testing and acceptance criteria for a physical medical device, not an AI-powered one. The studies focus on the physical and functional performance of the catheter system.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various tests and their corresponding results, with the acceptance criterion implicitly being "PASS" for all samples meeting pre-determined criteria.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Shelf Life & Sterility | Sterilization Verification | Sterility Assurance Level of 1 x 10-6 | Verified |
| Aging Studies (Packaging & Functionality) | Remain functional for labeled expiration date | Met acceptance criteria | |
| Biocompatibility | Cytotoxicity - ISO MEM Elution | Test article non-cytotoxic (grade less than 2) | Non-cytotoxic |
| Sensitization - ISO Guinea Pig Maximization | No delayed dermal contact sensitization | Did not elicit sensitization | |
| Irritation - ISO Intracutaneous Reactivity | Differences in mean scores <= 1.0 | Requirements met | |
| Performance Testing | Simulated Use Testing | Deliverability, clot retrieval, integrity etc. | PASS |
| (Reperfusion System) | Lumen Patency Testing | Lumen patency under vacuum | PASS |
| Dimensional Verification | Conformance to specifications | PASS | |
| Luer Integrity | Meet ISO 80369-7:2016 | PASS | |
| Tensile Strength | Acceptable tensile strength | PASS | |
| Kink Resistance | No kinking at defined bend diameter | PASS | |
| Torsion Resistance | Integrity after rotation | PASS | |
| Tip Flexibility | Acceptable tip flexibility | PASS | |
| Air Leakage | Meet ISO 10555-1:2013 Annex D | PASS | |
| Liquid Leakage | Meet ISO 10555-1:2013 Annex C | PASS | |
| Static Burst | Meet ISO 10555-1:2013 Annex F | PASS | |
| Dynamic Burst | Mechanical integrity at specified pressures | PASS | |
| Hydrophilic Coating Integrity | Coating integrity after cycles | PASS | |
| Performance Testing | Dimensional Verification | Conformance to specifications | PASS |
| (Aspiration Tubing Set) | Tensile Strength | Acceptable tensile strength | PASS |
| Lumen Ovalization | Lumen patency under vacuum | PASS | |
| Joint Leaks | No leakage under vacuum | PASS | |
| Lumen Patency | Lumen patency under vacuum | PASS | |
| Simulated Use Testing | Use for clot retrieval in model | PASS | |
| Packaging Integrity | Meet ISO 11607-1 Part 1 | PASS | |
| Canister Compatibility | Connection under vacuum | PASS | |
| Flow Switch | Ability to stop fluid flow under vacuum | PASS | |
| Animal Studies | Safety & Performance (Subacute & Chronic) | No unacceptable adverse events; effective | Successful demonstration |
2. Sample Size and Data Provenance:
- Sample Size: The document repeatedly states "All samples" met predetermined acceptance criteria for the non-clinical (benchtop) tests. Specific numerical sample sizes are not provided for these tests. For the animal studies, it mentions "Two chronic animal studies."
- Data Provenance: The data is derived from controlled laboratory and animal studies, not patient data. The country of origin is not explicitly stated, but the company is based in San Mateo, California, implying the studies were likely conducted in the US or under US regulatory standards. The studies are by nature prospective, as they are designed to test the device's performance according to predefined protocols.
3. Number of Experts and Qualifications for Ground Truth for the Test Set:
- This device clearance is based on demonstrable physical and functional properties, guided by engineering standards and biological testing, rather than human expert interpretation of data for ground truth (like in an AI imaging study).
- Therefore, the concept of "experts establishing ground truth for the test set" in the context of human interpretation of medical images (which is relevant for AI) does not apply directly to this type of device testing. Ground truth here is established through objective measurements, chemical analyses, and direct observation of physical performance against established engineering and biological standards (e.g., ISO standards, GLP for animal studies).
4. Adjudication Method for the Test Set:
- Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human readers provide subjective assessments that need to be aggregated or resolved.
- For the non-clinical and animal studies described, no such adjudication method is mentioned or relevant. The results are quantitative measurements or observations against predefined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to assess the impact of an AI system on human reader performance, typically in diagnostic imaging.
- The document describes testing for a physical medical device (catheter and tubing), not an AI system. Its "effectiveness" is demonstrated through its physical performance (e.g., ability to retrieve clots in a simulated environment, biocompatibility, durability) and successful outcomes in animal models.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone study in the context of an "algorithm only" was not done. As stated, this is a physical medical device. The "performance testing" sections describe the standalone performance of the physical device components (e.g., tensile strength, lumen patency).
7. Type of Ground Truth Used:
- Objective Test Results: For non-clinical (benchtop) tests, the "ground truth" is established by direct measurement and observation against pre-defined engineering specifications and international standards (e.g., ISO standards).
- Biological Outcomes: For biocompatibility, ground truth is established through standardized biological assays (e.g., cytotoxicity, sensitization, irritation tests) with clear pass/fail criteria.
- Animal Study Observations: For animal studies, ground truth involves in-life observations, and post-mortem assessment of relevant tissues, as well as the demonstration of safety and predetermined performance parameters (e.g., clot retrieval). The studies were conducted according to Good Laboratory Practices (GLP), which ensures scientific rigor and documented results as "ground truth."
8. Sample Size for the Training Set:
- Not applicable. This document describes the clearance of a medical device based on its physical and biological performance, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set mentioned or implied in this document as it does not relate to an AI device.
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April 11, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Route 92 Medical, Inc. Kirsten Valley Chief Operating Officer 155 Bovet Road, Suite 100 San Mateo, California 94402
Re: K223530
Trade/Device Name: Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: March 10, 2023 Received: March 10, 2023
Dear Kirsten Valley:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS)
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,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K223530
Device Name
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Indications for Use (Describe)
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated for use in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
| 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 K223530
| Sponsor: | Route 92 Medical, Inc.155 Bovet Road, Suite 100San Mateo, CA 94402Phone: 650-581-1179 |
|---|---|
| Contact: | Kirsten Valley |
| Date Prepared: | April 7, 2023 |
| Device Name: | Route 92 Medical Full Length 070 Reperfusion System andAspiration Tubing Set |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Thrombus Retriever (Product Code NRY, 21CFR 870.1250) |
| Device Classification | Class II |
| Predicate Device: | Penumbra System ACE 68 Reperfusion CatheterK161064 |
| Reference Device: | Route 92 Medical Full Length 070 Access System,K222743 |
Device Description
The Aspiration Catheter and Tenzing 7 Delivery Catheter comprise the Route 92 Medical Full Length 070 Reperfusion System. The Route 92 Medical Full Length 070 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.
The Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 7 Delivery Catheter is a single-lumen variable stiffness catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.
The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.
For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set, along with a legally marketed canister and accessories kit.
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Indications for Use
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
Comparison to the Predicate Device
The method of action, design, and materials of the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set are substantially equivalent to the predicate device as shown in the following table.
| Attribute | Predicate DevicePenumbra System ACE 68Reperfusion Catheter, K161064 | Subject DeviceRoute 92 Medical Full Length 070Reperfusion System and AspirationTubing Set |
|---|---|---|
| Indicationsfor Use | The Penumbra System is intended foruse in the revascularization of patientswith acute ischemic stroke secondaryto intracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset. | The Route 92 Medical Full Length070 Reperfusion System andAspiration Tubing Set is indicated foruse in the revascularization of patientswith acute ischemic stroke secondaryto intracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset. Patients who are ineligible forintravenous tissue plasminogenactivator (IV t-PA) or who failed IV t-PA therapy are candidates fortreatment. |
| DeviceDescription | The Penumbra System ACE 68Reperfusion Catheter includes anaspiration catheter, a shapingmandrel, a peel-away introducersheath, and an RHV. | The Route 92 Medical Full Length070 Reperfusion System includes anAspiration Catheter and a Tenzing 7Delivery Catheter and is used with theRoute 92 Medical Aspiration TubingSet. |
| User | Physicians trained in neurovascularinterventional techniques | Same |
| AnatomicalSites | Neurovasculature only | Same |
| Attribute | Predicate DevicePenumbra System ACE 68Reperfusion Catheter, K161064 | Subject DeviceRoute 92 Medical Full Length 070Reperfusion System and AspirationTubing Set |
| Materials | Polymers and metals commonly usedin the manufacture of medical devices | Same |
| Sterilization | 100% ethylene oxide | Same |
| Aspiration Catheter | ||
| InnerDiameter | 0.068" | 0.070" |
| OuterDiameter | 0.084" | 0.084" |
| Length | 115, 120, 125, 127, 132 cm | 132 cm |
| Delivery Catheter | ||
| InnerDiameter | Not applicable | 0.019" |
| OuterDiameter | Not applicable | 0.062" |
| Length | Not applicable | 151 cm |
| Compatibility:Pump forAspiration | Penumbra Aspiration Pump is aportable vacuum pump designed foruse in hospital settings which operateson AC power at a frequency of 60 Hz.The Penumbra Pump is provided non-sterile and is used outside the sterilefield. | Commercially available vacuumpump designed for use in hospitalsettings that is compatible with theRoute 92 Medical ReperfusionSystem and provides a constantvacuum of -25 inHg to -27.5 inHg. |
| Aspiration Tubing | ||
| InnerDiameter | 0.110" | 0.110" |
| OuterDiameter | 0.188" | 0.188" |
| Length | 112" | 112" |
| Materials | Polyurethane, Nylon, Polycarbonateand PVC | Polyurethane, Nylon, Polycarbonateand PVC |
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Non-Clinical Testing
Shelf Life and Sterility
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The Reperfusion System and Aspiration Tubing are sterilized using an ethylene oxide sterilization cycle that was verified to a sterility assurance level of 1 x 10-6 in accordance with ISO 11135. Aging studies established that the subject device and packaging remain functional for the labeled expiration date. Aging studies for packaging integrity, seal strength, and device functionality were performed and met the acceptance criteria.
Biocompatibility Testing
The patient-contacting materials of the Reperfusion System were unchanged compared to the K222743 Reference Device; therefore, no additional biocompatibility testing was required.
All patient-contacting components of the Aspiration Tubing were evaluated for biocompatibility in accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Per ISO 10993-1, the Route 92 Medical Aspiration Tubing Set is a device that has limited (≤24 hours) contact with intact skin. A summary of the biocompatibility testing is provided below.
| Aspiration Tubing Set | |||
|---|---|---|---|
| Test | Results | Conclusions | |
| Cytotoxicity - ISOMEM Elution | The test article extract showed no evidence ofcausing cell lysis or toxicity. The test articleextract met the requirements of the test as gradewas less than 2. | The test article is non-cytotoxic. | |
| Sensitization - ISOGuinea PigMaximizationSensitization Test(Normal Saline andSesame Oil) | The test article extracts showed no evidence ofcausing delayed dermal contact sensitization inthe guinea pig. The test article was not considereda sensitizer in the test. | The test article did notelicit a sensitizationresponse. | |
| Irritation - ISOIntracutaneousReactivity (NormalSaline and Sesame Oil) | The test article met the requirements of the testsince the difference between each test articleextract overall mean score and correspondingcontrol extract overall mean score was 1.0 or lessfor both sodium chloride and sesame oil testarticle extracts. | Requirements of theISO intracutaneousreactivity test havebeen met for the testarticle. |
Performance Testing
The successful completion of the performance testing listed in the following tables demonstrates that the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is suitable for its intended use.
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| Full Length 070 Reperfusion System | ||
|---|---|---|
| Test | Test Method | Results |
| Simulated UseTesting | Deliverability, clot retrieval, device integrity, kink andaspiration resistance, lumen patency, durability andcompatibility with accessory devices were evaluated in aneurovascular model. | PASSAll samples met the pre-determined acceptancecriteria |
| Lumen PatencyTesting | Test specimens were tested for lumen patency undervacuum. | PASSAll samples met the pre-determined acceptancecriteria |
| DimensionalVerification | Device dimensions were measured to confirmconformance to the specifications. | PASSAll samples met the pre-determined acceptancecriteria |
| Luer Integrity | Tested per ISO 80369-7:2016. | PASSAll samples met the pre-determined acceptancecriteria |
| TensileStrength | The tensile strength of the catheter sections and bondswas tested. | PASSAll samples met the pre-determined acceptancecriteria |
| KinkResistance | Test specimen segments were formed into a definedbend diameter to evaluate kink resistance. | PASSAll samples met the pre-determined acceptancecriteria |
| TorsionResistance | The test specimens were rotated to evaluate integrityafter rotation. | PASSAll samples met the pre-determined acceptancecriteria |
| Tip Flexibility | Test specimens were tested for tip flexibility. | PASSAll samples met the pre-determined acceptancecriteria |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASSAll samples met the pre-determined acceptancecriteria |
| Full Length 070 Reperfusion System | ||
| Test | Test Method | Results |
| LiquidLeakage | Tested per ISO 10555-1:2013 Annex C. | PASSAll samples met the pre-determined acceptancecriteria |
| Static Burst | Tested per ISO 10555-1:2013 Annex F. | PASSAll samples met the pre-determined acceptancecriteria |
| Dynamic Burst | Mechanical integrity was maintained up to the specifiedpressures. | PASSAll samples met the pre-determined acceptancecriteria |
| HydrophilicCoatingIntegrity | The integrity of the hydrophilic coating was evaluatedafter multiple insertion and withdrawal cycles. | PASSAll samples met the pre-determined acceptancecriteria |
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| Aspiration Tubing Set | ||
|---|---|---|
| Test | Test Method | Results |
| DimensionalVerification | Device dimensions were measuredto confirm conformance to thespecifications. | PASSAll samples met the pre-determinedacceptance criteria |
| Tensile Strength | Test specimens were tested fortensile strength. | PASSAll samples met the pre-determinedacceptance criteria |
| LumenOvalization | Lumen patency under vacuum wastested. | PASSAll samples met the pre-determinedacceptance criteria |
| Joint Leaks | Leakage under vacuum was tested. | PASSAll samples met the pre-determinedacceptance criteria |
| Lumen Patency | Test specimens were tested forlumen patency under vacuum. | PASSAll samples met the pre-determinedacceptance criteria |
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| Aspiration Tubing Set | ||
|---|---|---|
| Test | Test Method | Results |
| Simulated Use Testing | Use for clot retrieval was evaluated in a neurovascular model. | PASSAll samples met the pre-determined acceptance criteria |
| Packaging Integrity | Tested per ISO 11607-1 Part 1. | PASSAll samples met the pre-determined acceptance criteria |
| Canister Compatibility | Connection to collection canister under vacuum was tested. | PASSAll samples met the pre-determined acceptance criteria |
| Flow Switch | Ability to stop fluid flow under vacuum was tested. | PASSAll samples met the pre-determined acceptance criteria |
Animal Studies
Two chronic animal studies were conducted according to good laboratory practices (GLP) in a swine model to demonstrate the safety and performance of the Route 92 Medical Reperfusion System and to establish substantial equivalence to the Predicate Device. Study animals were terminated at either subacute (3-day) or chronic (30-day) time points. Devices were evaluated under worst-case clinical conditions, including soft and firm clot aspiration, wedge aspiration, downstream organ assessment, inlife observations, and postmortem assessment of relevant tissues (treated vessels, downstream vessels).
Substantial Equivalence
The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set has the same intended use, similar technological characteristics, and same method of action as the predicate device. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness of the device. The successful completion of biocompatibility testing, bench performance testing, and animal testing demonstrates that the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is substantially equivalent to the predicate device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).