(102 days)
The RevCore Thrombectomy Catheter is indicated for:
• The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature.
The RevCore Thrombectomy Catheter is a single-use, sterile medical device designed for use in the peripheral vasculature. The RevCore Thrombectomy Catheter comprises reinforced polymeric and metal coaxial shafts terminating in an expandable coring element. Two ports are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the RevCore Thrombectomy Catheter distal tip and coring element are radiopaque. The RevCore Thrombectomy Catheter consists of a distal laser-cut nitinol coring element, catheter shafts, and a handle, providing wall-to-wall contact, allowing the engagement and retrieval of clot from blood vessels and from implanted venous stents. The catheter shafts introduce the nitinol coring element percutaneously. The handle allows the physician to retract and turn the nitinol coring element to engage clot, as well as control the diameter of the nitinol coring element with a knob.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: RevCore™ Thrombectomy Catheter
The document states that the RevCore Thrombectomy Catheter underwent various performance, biocompatibility, and sterilization tests to demonstrate substantial equivalence to its predicate and reference devices. However, it does not explicitly provide a table of acceptance criteria with corresponding performance results for each test. Instead, it lists the types of tests performed and generally states that "acceptance criteria were met."
Therefore, I will create a table summarizing the types of tests performed and the general statement about their success.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
| Acceptance Criteria Category (Implied) | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Packaging Tests & Inspections | - Pouch Seal Inspection- Pouch Dye Penetration- Pouch Bubble Leak- Aseptic Presentation | All non-clinical test results demonstrated that acceptance criteria were met. |
| Dimensions & Key Characteristics | - Visual and Dimensional Inspections (RevCore Catheter, RevCore Coring Element, RevCore Delivery Catheter)- Guidewire Compatibility | All non-clinical test results demonstrated that acceptance criteria were met. |
| Performance & Functional Evaluation | - Deairing/Flushing Testing- Knob Torque Testing- Deployment and Retraction Force through the Delivery Catheter- Coring Element Retraction into Delivery Catheter Inspection- Distal Catheter Kink Radius Testing- Coring Element Durability Inspection (Post-Simulated Use)- Insertion through Sheath- Retraction Force through Sheath- Sheath Inspection (Post-Simulated Use)- Leakage Testing, Sheath (Post-Simulated Use)- Vacuum Testing, Sheath (Post-Simulated Use)- Leakage Testing, RevCore Catheter (Post-Simulated Use)- Delivery Catheter Durability Inspection (Post-Simulated Use)- Simulated Use Tracking and Tensile Testing (Post-Simulated Use)- Simulated Use Tracking and Torque Testing (Post-Simulated Use)- Corrosion Testing- Particulate Matter Determination- Luer Testing- Safety Testing in Stent Model | All non-clinical test results demonstrated that acceptance criteria were met. |
| Characterization Tests | - Radial Force Characterization- Efficacy Testing (Clot & Stent Model)- SEM of Stents/RevCore Coring Elements Post-Treatment | All non-clinical test results demonstrated that acceptance criteria were met. |
| Leveraged Tests | - Pouch Seal Strength- Simulated Use Tracking and Rotation Testing- Delivery Catheter Radiopacity | All non-clinical test results demonstrated that acceptance criteria were met. |
| Pre-Clinical Study | - GLP Animal Study (to evaluate safety and performance) | The GLP animal testing met the predetermined acceptance criteria. |
| Biocompatibility | - Cytotoxicity- Sensitization- Intracutaneous Reactivity- Acute Systemic Toxicity- Pyrogenicity (Material Mediated)- Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity, Platelet and Leukocyte, Partial Thromboplastin Time (PTT)) | All non-clinical test results demonstrated that acceptance criteria were met. |
| Sterilization | - Sterilization using EtO to achieve a sterility assurance level (SAL) of 10^-6 in accordance with ISO 11135:2014 and AAMI TIR 28:2016. | Successfully achieved SAL of 10^-6 without deviations. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for each of the listed tests (e.g., number of catheters tested for durability, number of animals in the GLP study).
- Sample Sized Used for the Test Set: Not specified in detail for individual tests. A "GLP Animal Study" was performed, implying animal subjects were used, but the number is not provided.
- Data Provenance: The studies are described as "non-clinical performance testing" and a "Pre-Clinical Study (GLP Animal Study)," indicating experimental lab/animal data rather than human patient data, and thus no country of origin is specified in that context. The context is a regulatory submission to the FDA in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The testing described is performance, preclinical animal, and biocompatibility testing for a medical device, which typically relies on established laboratory protocols, measurement standards, and animal models rather than expert consensus on ground truth in the context of imaging or diagnostic AI.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human review of data (e.g., medical images) to establish ground truth or resolve discrepancies. The provided document describes device performance and preclinical animal testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. Such studies are typically conducted for diagnostic devices or AI algorithms that involve human interpretation, to assess the impact of the device on reader performance. This document pertains to a thrombectomy catheter, which is an interventional device, not a diagnostic one involving human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device described is an interventional medical device (thrombectomy catheter), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
For the performance and functional tests, the "ground truth" would be established engineering specifications, material properties, and predetermined acceptance thresholds for various physical and mechanical properties. For the GLP Animal Study, the "ground truth" would be the observed safety and performance outcomes against predefined endpoints in the animal model. For biocompatibility, the ground truth is established by adherence to ISO 10993-1 standards and the specific metrics of those tests (e.g., cytotoxicity levels, hemocompatibility parameters).
8. The Sample Size for the Training Set
This question is not applicable as the device described is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device described is a physical medical device, not an AI or machine learning model.
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March 14, 2023
Inari Medical, Inc. Suzanne Moreno Sr. Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618
Re: K223609
Trade/Device Name: RevCore™ Thrombectomy Catheter. Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: February 23, 2023 Received: February 24, 2023
Dear Suzanne Moreno:
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 medical devices and radiation-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,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.03.14
09:29:30 -04'00'
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) K223609
Device Name RevCoreTM Thrombectomy Catheter
Indications for Use (Describe) The RevCore Thrombectomy Catheter is indicated for:
· The non-surgical removal of thrombi and emboli from blood vessels.
· Injection, infusion , and/or aspiration of contrast media and other fluids into or from a blood vessel.
The RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature system
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 logo for Inari Medical. The logo consists of a purple circle with three orange lines going through it on the left. To the right of the circle is the word "INARI" in large, purple, bold letters, and below that is the word "MEDICAL" in smaller, gray letters.
510(k) Summary K223609 RevCore™ Thrombectomy Catheter
The following "510(k) Summary" of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
1.0 Submitter Information [ 21 CFR 807.92(a) (1)]
| Submitter: | Inari Medical, Inc. |
|---|---|
| Address: | 6001 Oak Canyon, Suite 100Irvine, CA 92618 USA |
| EstablishmentRegistration #: | 3020347218 |
| Contact: | Suzanne Moreno |
| Title: | Sr. Regulatory Affairs Specialist |
| Telephone: | (949) 694-9459 |
| Suzanne.Moreno@inarimedical.com |
Date Prepared: January 04, 2023
2.0 Device Information [21 CFR 807.92 (a) (2)]
| Device/Trade Name: | RevCore™ Thrombectomy Catheter |
|---|---|
| Device Classification: | Class II |
| Primary Product Code: | QEW |
| Regulation: | 21 CFR 870.5150 |
| Regulation Name: | Embolectomy catheter |
| Common Name: | Embolectomy catheter |
| Classification Panel: | 74-Cardiovascular |
3.0 Predicate, and Reference Device Information [21 CFR 807.92(a) (3)]
| Predicate Device | 510(k)No. | DecisionDate | 510(k) Holder |
|---|---|---|---|
| ClotTriever BOLD Catheter | K212632 | 10/18/2021 | Inari Medical, Inc. |
| Reference Device | 510(k)No. | DecisionDate | 510(k) Holder |
| FlowTriever Retrieval/AspirationSystem | K201541 | 12/04/2020 | Inari Medical, Inc. |
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Image /page/4/Picture/0 description: The image is a logo for Inari Medical. The logo features a purple circle with three orange lines going through it on the left side. To the right of the circle is the word "INARI" in large, purple letters, and below that is the word "MEDICAL" in smaller, gray letters.
4.0 Device Description [21 CFR 807.92(a) (4)1
The RevCore Thrombectomy Catheter is a single-use, sterile medical device designed for use in the peripheral vasculature. The RevCore Thrombectomy Catheter comprises reinforced polymeric and metal coaxial shafts terminating in an expandable coring element. Two ports are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the RevCore Thrombectomy Catheter distal tip and coring element are radiopaque. The RevCore Thrombectomy Catheter consists of a distal laser-cut nitinol coring element, catheter shafts, and a handle, providing wall-to-wall contact, allowing the engagement and retrieval of clot from blood vessels and from implanted venous stents. The catheter shafts introduce the nitinol coring element percutaneously. The handle allows the physician to retract and turn the nitinol coring element to engage clot, as well as control the diameter of the nitinol coring element with a knob.
5.0 Intended Use/Indications for use of device and Indications for Use [21 CFR 807.92(a) (5)]
Indications for Use
The RevCore Thrombectomy Catheter is indicated for:
- . The non-surgical removal of thrombi and emboli from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into . or from a blood vessel.
The RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature.
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6.0 Summary of Substantial Equivalence [21 CFR 807.92 (a) (6)]
The RevCore Thrombectomy Catheter is similar/same in indications for use, fundamental design, principles of operation, materials, labeling/packaging, and sterilization compared to the Inari owned devices, the predicate, the ClotTriever BOLD Catheter (K212632), and the reference device, the FlowTriever Retrieval/Aspiration System (K201541).
| Subject | Predicate Device | Reference Device | Subject | Predicate Device | Reference Device | ||
|---|---|---|---|---|---|---|---|
| Device | RevCore Thrombectomy Catheter | ClotTriever BOLD Catheter | FlowTriever Retrieval/Aspiration System | Device | RevCoreThrombectomy Catheter | ClotTriever BOLDCatheter | FlowTrieverRetrieval/AspirationSystem |
| 510(k) Number | K223609 | K212632 | K201541 | 510(k) Number | K223609 | K212632 | K201541 |
| Manufacturer | Inari Medical | Inari Medical | Inari Medical | DeviceDescription | The RevCore Catheteris a single-use, sterile,minimally invasivemedical device designedfor use in the peripheralvasculature. | The ClotTriever BOLDCatheter is a single-use,sterile, minimally invasivemedical device designedfor use in the peripheralvasculature. | The FlowTriever Systemis a single-use, sterile,minimally invasivemedical device designedfor use in the peripheralvasculature. |
| Product code | QEW | QEW | QEWKRA | The RevCore Catheter iscomprised of reinforcedpolymeric and metalliccoaxial shafts terminatingin an expandable coringelement. | The ClotTriever BOLDCatheter is comprised ofreinforced polymeric andmetallic coaxial shaftsterminating in anexpandable coringelement and thrombuscollection bag. | The FlowTrieverCatheters are comprisedof reinforced polymericand metallic coaxialshafts terminating in anexpandable coringelement. | |
| Device Class | Class II | Class II | Class II | Two ports are providedfor de-airing the cathetershafts. | Three ports are providedfor de-airing the cathetershafts. | One port is provided forde-airing the cathetershafts. | |
| Indications for Use Statements | The RevCore Thrombectomy Catheter is indicated for:• The non-surgical removal of thrombi and emboli from blood vessels.• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.The RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature. | The ClotTriever BOLD Catheter is indicated for:• The non-surgical removal of thrombi and emboli from blood vessels.• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.The ClotTriever BOLD Catheter is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). | The FlowTriever 2 Catheter is indicated for:• The non-surgical removal of thrombi and emboli from blood vessels.• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.The FlowTriever 2 Catheter is intended for use in the peripheral vasculature. | To aid in fluoroscopicvisualization, theRevCore Catheterdistal tip is radiopaque. | To aid in fluoroscopicvisualization, theClotTriever BOLDCatheter distal tip isradiopaque. | To aid in fluoroscopicvisualization, theFlowTriever Catheterdistal tip is radiopaque. | |
| Principles ofoperation | The coring element iscomposed of self-expanding nitinol and thediameter is manuallycontrolled by a knob inthe handle. | The coring element iscomposed of self-expanding nitinol and thediameter is manuallycontrolled by a plunger inthe handle. | The disk(s) arecomposed of self-expanding nitinol whichare deployed by manuallyretracting the outerDelivery Catheter. | ||||
| The coring element isretracted through thevessel to engage andremove thrombus andemboli. | The coring element isretracted through thevessel to engage andremove thrombus andemboli. | The coring element isretracted through thevessel to engage andremove thrombus andemboli. | |||||
| The device and capturedclot can then be removedfrom the vessel throughthe introducer sheath. | The device and capturedclot can then be removedfrom the vessel throughthe introducer sheath. | The device and capturedclot can then be removedfrom the vessel throughthe introducer sheath. |
The comparisons are listed in the table below:
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| Subject | Predicate Device | Reference Device | |
|---|---|---|---|
| Device | RevCoreThrombectomy Catheter | ClotTriever BOLDCatheter | FlowTrieverRetrieval/AspirationSystem |
| 510(k) Number | K223609 | K212632 | K201541 |
| Power Source | Manually operated | Manually operated | Manually operated |
| Sterile | SAL 10-6, EO | SAL 10-6, EO | SAL 10-6, EO |
| Number ofdisks / coringelements | Model 44-101: 1 | Model 42-102: 1 | Model 11-102: 1Model 10-104: 3 |
| Recommendedvessel sizetreatment range | Model 44-101:6mm - 20mm | Model 42-1026mm - 16mm | Model 11-1026mm - 16mmModel 10-10419mm - 25mm |
| Maximum Disk /Coring ElementSize | Model 44-101: 24.0mm | Model 42-102: 16.0mm | Model 11-102: 17.0mmModel 10-104: 27.9mm |
| Disk / coringelementmaterial | Nitinol | Nitinol | Nitinol |
| DeliveryCatheter shaftmaterials | Pebax 6333 SA01 MED,Pebax 5533 SA01 MED,304V stainless steel,PTFE Liner | Pebax 6333 SA01 MED,Pebax 5533 SA01 MED,304V stainless steel,PTFE Liner | Pebax 7233 SA01 MED,Pebax 4033 SA01 MED,304V stainless steel,PTFE Liner |
| Tip Materials | Pebax 7233 SA01 MED,45% Tungsten | Pebax 7233 SA01 MED,70% Tungsten | Pebax 7233 SA01 MED,70% Tungsten |
| DeliveryCatheter OD | 3.9 mm | 3.9 mm | 3.8 mm |
| DeliveryCatheter length | 80 cm | 80 cm | 120 cm |
| Guidewirecompatibility | .035" | .035" | .035" |
7.0 Performance Testing [21 CFR 807.92(b)(1)]
In accordance with the Design Failure Modes and Effects Analysis, verification and validation tests were identified to support the substantial equivalence of the RevCore Thrombectomy Catheter to the predicate device, the ClotTriever BOLD Catheter (K212632), and the reference device, the FlowTriever Retrieval/Aspiration System (K201541).
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7.1 Performance Testing
The following tests were performed for the RevCore Thrombectomy Catheter:
Packaging Tests & Inspections
- Pouch Seal Inspection ●
- Pouch Dye Penetration ●
- Pouch Bubble Leak ●
- Aseptic Presentation
Dimensions & Key Characteristics
- Visual and Dimensional Inspections ●
- o RevCore Catheter
- RevCore Coring Element o
- RevCore Delivery Catheter o
- Guidewire Compatibility ●
Performance & Functional Evaluation
- Deairing/Flushing Testing ●
- Knob Torque Testing ●
- Deployment and Retraction Force through the Delivery Catheter ●
- Coring Element Retraction into Delivery Catheter Inspection ●
- Distal Catheter Kink Radius Testing ●
- Coring Element Durability Inspection (Post-Simulated Use) ●
- Insertion through Sheath
- Retraction Force through Sheath ●
- Sheath Inspection (Post-Simulated Use) ●
- Leakage Testing, Sheath (Post-Simulated Use) ●
- Vacuum Testing, Sheath (Post-Simulated Use) ●
- Leakage Testing, RevCore Catheter (Post-Simulated Use) ●
- Delivery Catheter Durability Inspection (Post-Simulated Use) ●
- Simulated Use Tracking and Tensile Testing (Post-Simulated Use) ●
- Simulated Use Tracking and Torque Testing (Post-Simulated Use) ●
- Corrosion Testing
- Particulate Matter Determination ●
- Luer Testing ●
- Safety Testing in Stent Model ●
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Characterization Tests
- Radial Force Characterization ●
- Efficacy Testing (Clot & Stent Model) ●
- SEM of Stents/RevCore Coring Elements Post-Treatment
Leveraged Tests
- Pouch Seal Strength ●
- Simulated Use Tracking and Rotation Testing ●
- Delivery Catheter Radiopacity ●
Pre-Clinical Study
A GLP Animal Study was successfully performed to evaluate the safety and performance of the RevCore Thrombectomy Catheter. The GLP animal testing met the predetermined acceptance criteria.
7.2 Biocompatibility
Biocompatibility testing for the RevCore Thrombectomy Catheter was completed in accordance with ISO 10993-1 including:
- Cytotoxicity ●
- Sensitization ●
- Intracutaneous Reactivity ●
- Acute Systemic Toxicity ●
- Pyrogenicity (Material Mediated)
- Hemocompatibility ●
- o Hemolysis
- Complement Activation O
- Thrombogenicity O
- Platelet and Leukocyte O
- Partial Thromboplastin Time (PTT) о
7.3 Sterilization
The subject device is sterilized using EtO to achieve a sterility assurance level (SAL) of 10°. The subject device has been adopted into a validated sterilization process in accordance with the principles of 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, and AAMI TIR 28:2016 (Product adoption and process equivalence for ethylene oxide sterilization) without deviations.
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7.4 Clinical Data [21 CFR 807.92(b) (2)]
Based on the similarities in the safety and effectiveness profiles of the subject predicate, and reference devices per their intended uses, no clinical studies were deemed necessary to support this submission.
All non-clinical test results demonstrated that acceptance criteria were met; therefore, the device conforms to established product specifications.
8.0 Conclusions Safety and Effectiveness SW [21 CFR 807.92(b) (3)]
The subject device has successfully passed all acceptance criteria for nonclinical performance testing and biocompatibility, demonstrating that the subject device is substantially equivalent to the legally marketed predicate ClotTriever BOLD Catheter (K212632).
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).