(222 days)
MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.
The MultiStage Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree. Balloons designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon material is made of Pebax material. The MultiStage Balloon Dilatation Catheter designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through a minimum 2.8mm working channel bronchoscope. The Catheter hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture.
This document is a 510(k) Summary for a medical device called the "MultiStage Balloon Dilatation Catheter." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not describe specific acceptance criteria and a study proving the device meets those criteria in the way one might expect for a novel AI/software device.
Instead, the document focuses on demonstrating that the proposed device is "substantially equivalent" to a predicate device. This is achieved by showing similar intended use, technological characteristics, and principles of operation, and by performing non-clinical tests to ensure safety and effectiveness.
Here's an attempt to extract the requested information, understanding that it will be framed within the context of substantial equivalence rather than a direct performance study against defined acceptance criteria for, for example, a diagnostic accuracy claim:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in terms of specific quantitative thresholds to be met for diagnostic performance (as would be typical for an AI/software device making a diagnostic claim). Instead, the "acceptance criteria" are implied by the standards and performance characteristics tested for a physical medical device, and the "reported device performance" is that the device passed these tests and is considered "safe and effective."
| Acceptance Criteria (Implied by Standards & Tests) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1) | All tests passed: No cytotoxicity, not an irritant, not a sensitizer. |
| Shelf Life (ASTM F1980) | All tests passed. |
| Sterilization (ISO 11607-1:2019, ISO 11135:2014) | Sterile with SAL of 10⁻⁶; all tests passed. |
| Visual Inspection | (Implied: Passed standard visual inspection) |
| Bacteriostasis performance of pouch | (Implied: Passed) |
| Dye penetration | (Implied: Passed) |
| Pouch | (Implied: Passed) |
| Tension test | (Implied: Passed) |
| Guidewire compatibility test | (Implied: Passed) |
| Channel compatibility | (Implied: Passed) |
| Product Dimensional Inspection | (Implied: Passed) |
| Balloon fatigue; No leakage and damage when inflation | (Implied: Passed) |
| Balloon inflation and deflation time | (Implied: Passed) |
| Balloon rated burst pressure (RBP) | (Implied: Passed) |
| Peak tensile | (Implied: Passed) |
| Leakage Test | (Implied: Passed) |
| Hydratability | (Implied: Passed) |
| Corrosion resistance | (Implied: Passed) |
| X-ray detectability | (Implied: Passed; marker bands provide visual reference) |
| Torsion test | (Implied: Passed) |
| Overall Safety and Effectiveness | Considered safe and effective for its intended use. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "non-clinical tests" which include physical, chemical, and biological performance testing of the device and its components. The sample sizes for these specific engineering and biocompatibility tests are not disclosed in this summary. The data provenance is primarily from laboratory testing of the manufactured device. There is no mention of patient data or its origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of submission. The device is a physical medical instrument, not a diagnostic AI/software that requires expert-established ground truth from clinical data. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and engineering principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to establish a consensus ground truth for diagnostic decisions. This submission focuses on non-clinical performance and substantial equivalence to a predicate device.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, not for a physical balloon dilatation catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to AI/software performance. The device is a physical catheter, so a "standalone" algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the specifications, requirements, and methods outlined in the referenced international standards (e.g., ISO 10993-1 for biocompatibility, ASTM F1980 for shelf life, ISO 11135 and ISO 11607-1 for sterilization). There is no clinical ground truth involving patient outcomes or expert consensus for this type of submission.
8. The sample size for the training set
This is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set for model development.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a physical medical device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 1, 2023
Dongguan TT Medical, Inc. % Mingzi Hussey Principal Regulatory Consultant Zi-medical, Inc. 93 Springs Rd Bedford, Massachusetts 01730
Re: K222187
Trade/Device Name: MultiStage Balloon Dilatation Catheter Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: February 2, 2023 Received: February 2, 2023
Dear Mingzi Hussey:
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,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K222187
Device Name MultiStage Balloon Dilatation Catheter
Indications for Use (Describe)
MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.
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 a logo for "t-MED". The logo features a stylized letter "A" in orange, with a circular arc behind it, also in orange. The text "t-MED" is positioned below the "A", with "t-" in a smaller font size than "MED". The overall design is simple and modern, using a bold color to draw attention.
510(k) Summary
[As required by 21 CFR 807.92]
1. Submission Sponsor
Dongguan TT Medical, Inc. Address: BLD #1, 1 Taoyuan Road, Songshan Lake, Dongguan, Guangdong, 523808 China Phone: +86 15553341910 Contact: Yuying Bi, Regulatory Affairs Specialist Email: ybi @ttmedicalinc.com
2. Submission Correspondent
Mingzi Hussey Zi-medical, Inc. Address: 93 Springs Rd, Bedford, MA 01730 US Phone: 206-981-0675 Email: mingzi@zi-medical.com
3. Date Prepared
May 5th, 2022
4. Device Identification
510(k) Number: K222187 Trade Name: MultiStage Balloon Dilatation Catheter Common Name/Classification Name: Balloon Dilatation Catheter Product Code: KTI Regulation Number: 21 CFR 874.4680 Regulation Class: Class II Review Panel: Ear Nose & Throat (ENT)
5. Predicate Device
The proposed device is substantially equivalent to the following predicate device:
| Applicant | Device name | 510(k) Number | Product code |
|---|---|---|---|
| Boston ScientificCorp | CRE Pulmonary Balloon DilatationCatheter | K170759 | KTI |
6. Device Description
The MultiStage Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree. Balloons designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon material is made of Pebax material. The MultiStage Balloon Dilatation Catheter
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Image /page/4/Picture/1 description: The image shows a logo for t-MED. The logo features a large, orange triangle with a circle behind it. The triangle is the most prominent element of the logo, and the circle adds a sense of completeness. Below the triangle, the text "t-MED" is written in a simple, sans-serif font.
designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through a minimum 2.8mm working channel bronchoscope. The Catheter hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture.
7. Indication for Use
MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.
8. Comparison of Technological Characteristics
The following table compares the proposed device with the predicate device in terms of intended use, technological characteristics and principles of operation, and it provides detailed information for determining substantial equivalences.
| ITEM | Proposed Device | Predicate Device | Comments |
|---|---|---|---|
| Trade name | MultiStage Balloon DilatationCatheter | CRE Pulmonary BalloonDilatation Catheter | / |
| 510(K)Submitter | Dongguan TT Medical, Inc. | Boston Scientific Corp | / |
| 510(K) Number | K222187 | K170759 | / |
| ClassificationRegulation | 21 CFR 874.4680 | 21 CFR 874.4680 | Same |
| Classificationand Product Code | Class II,KTI | Class II,KTI | Same |
| Common name | Balloon Dilatation Catheter | Balloon Dilatation Catheter | Same |
| Bronchoscope | Single-Use | Single-Use | Same |
| Intended Use | MultiStage balloon dilatationcatheter is intended to be used todilate strictures located in theairway tree. | CRETM Pulmonary Balloon DilatorCatheters is Intended to be used toendoscopically dilate strictures ofthe airway tree. | MultiStage BalloonDilatation Catheter andthe predicate device aresame in terms ofindication for use. Theyare both to be used todilate strictures locatedin the airway tree. |
| AnatomicalLocations | Airway tree | Airway tree | Same |
| Components | 1. Tip 2. Balloon 3. MarkerBand 4. Inner Tube 5. OuterTube 6. Strain Relief 7. Hub8. Protective Sheath 9. Mandrel | 1. Tip 2. Balloon 3. Marker Band4. Inner Tube 5. Outer Tube6. Stress Relief 7. Hub8. Protective Sheath 9. Mandrel | Same |
| Principle ofOperation | MultiStage balloon dilatationcatheter used to access theairway tree via a bronchoscope | The CRETM Pulmonary BalloonDilatation Catheter is used toaccess the airway tree via a | The only different is theworking channeldiameter: MultiStage |
General Comparison
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Premarket Notification – Traditional 510(k)
510(k) Summarv
Image /page/5/Picture/1 description: The image shows a logo for t-MED. The logo features a stylized letter "A" in orange, with a circular shape behind it. The text "t-MED" is written in a smaller font below the "A". The logo has a clean and modern design.
| 510(k) Summary | |||||
|---|---|---|---|---|---|
| for the purpose of dilatingstrictures. It is designed to passover a 0.035in (0.89mm)guidewire through its guidewirelumen or through a minimum 2.8mm working channelbronchoscope, balloon is capableof 3 distinct and progressivelylarger size diameters via controlledradial expansion | bronchoscope for the purpose ofdilating strictures. It is designed topass over a 0.035in (0.89mm)guidewire through its guidewirelumen or through a minimum 5.0mm working channelbronchoscope, balloon is capableof 3 distinct and progressivelylarger size diameters viacontrolled radial expansion | balloon dilatationcatheter has a minimum2.8mm working channel,which is better thanpredicate device'sminimum 5.0mmworking channel. Thedifference won'tincrease any new safetyand efficacy risk. | |||
| MarkerBand/Location | Two radiopaque mark are placedunder the balloon segment of thecatheter to provide visualreference points fluoroscopicallyfor balloon positioning within thestricture. | Two radiopaque mark are placedunder the balloon segment of thecatheter to provide visual referencepoints fluoroscopically for balloonpositioning within thestricture. | Same | ||
| How Supplied | Sterile, Single use only | Sterile, Single use only | Same | ||
| Sterilizationmethod | EO | EO | Same | ||
| Outer shaftdiameter | 2.5mm | 2.5mm | Same | ||
| Workinglength(mm) | 90, 180 | 110 | Different MultistageBalloon DilatationCatheter has two type ofworking length 90mmand 180mm, while thepredicate device only hasone working length,whichis 110mm. | ||
| Guiding wirechannel | 0.89mm | 0.89mm | Same | ||
| Inflated BalloonOD | InflatedBalloonOD (mm)6-7-88-9-1010-11-1212-13.5-1515-16.5-18 | InflationPressure(ATM)3-6-103-5.5-93-5-83-4.5-83.4.5-7 | Inflated BalloonOD (mm)8-9-1010-11-1212-13.5-1515-16.5-1818-19-20 | InflationPressure(ATM)3-5.5-93-5-83-4.5-83.4.5-73-4.5-6 | Multistage BalloonDilatation Catheter hasmore model to select inballoon OD andpressure. |
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Premarket Notification – Traditional 510(k) 510(k) Summary
Image /page/6/Picture/1 description: The image shows a logo for "t-MED". The logo is primarily orange and features a stylized letter "A" with a circle behind it. The text "t-MED" is written in a smaller font below the "A" symbol.
| Balloon Dilationlength | 30mm, 55mm | 30mm, 55mm | Same | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Inflation pressure | Inflated Balloon OD (mm) Inflation Pressure (ATM) 6-7-8 3-6-10 8-9-10 3-5.5-9 10-11-12 3-5-8 12-13.5-15 3-4.5-8 15-16.5-18 3.4.5-7 18-19-20 3-4.5-6 | Inflated Balloon OD (mm) Inflation Pressure (ATM) 8-9-10 3-5.5-9 10-11-12 3-5-8 12-13.5-15 3-4.5-8 15-16.5-18 3.4.5-7 18-19-20 3-4.5-6 | Multistage BalloonDilatation Catheter hasmore model to select inballoon OD andpressure. | ||||||||||||||||||||||||||
| Applicable tunnel | ≥15 Fr (2.8 mm) | ≥15Fr (5.0 mm) | DifferentMultiStage balloondilatation catheter hasa minimum 2.8mmworking channel,which is better thanpredicate device'sminimum 5.0mmworking channel. Thedifference won'tincrease any new safetyand efficacy risk. | ||||||||||||||||||||||||||
| Materials | 1. Tip: 100% Pebax2. Balloon: 100% Pebax3. Marker band: Tantalum4. Inner tube: 100% Pebax5. Outer tube: 99.8%Pebax: 0.2%Blue color additives6. Strain relief: 99.8% HDPE:0.2% White color additives7. Hub: 95% Polycarbonate:5% Bonding agent (Ethylenepropylene UV binder )8. Protective Sheath: 100%HDPE9. Mandrel: 100%Polyformaldehyde | 1. Balloon: 100% Pebax2. Marker band: Platinum iridium | Similar Compared withpredicate device markerband material isdifferent, the markerband does not touch thehuman body. Differencedo not raise newquestions of safety andefficacy. | ||||||||||||||||||||||||||
| Storagecondition andShippingcondition | Store in a cool, dry, dark place.Rotate inventory so that thosecatheters are used prior to theexpiration date on the packagelabel | Store in a cool, dry, dark place.Rotate inventory so that thosecatheters are used prior to theexpiration date on the packagelabel | Same | ||||||||||||||||||||||||||
| Packaging | Sterile single package. The | Sterile single package. Predicate | Same |
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Image /page/7/Picture/1 description: The image shows a logo for t-MED. The logo features a stylized orange triangle with a circle behind it. The text "t-MED" is written in black below the triangle.
| product is inserted into thedispenser, and put in sterile pouch,the sterile pouch material: PET12/SPE-250 (LK)composite film and Tyvek 1073Bdialysis paper, finally put intothe carton. | Device is inserted into HDPE Die-cut insert card, and put insterile pouch, the sterile pouchmaterial: PET12/ SPE-250 (LK)composite film and Tyvek 1073Bdialysis paper. | ||
|---|---|---|---|
| Shelf-life | 3 | 3 | Same |
| Cytotoxicity | Comply with ISO10993-5, nocytotoxicity effect | Comply with ISO10993-5, nocytotoxicity effect | Same |
| Irritation | Comply with ISO10993-10, not anirritant | Comply with ISO10993-10, not anirritant | Same |
| Sensitization | Comply with ISO10993-10, not asensitizer. | Comply with ISO10993-10, not asensitizer. | Same |
MultiStage Balloon Dilatation Catheter has 24 models:
| Nominal Balloon Diameter | ||||||
|---|---|---|---|---|---|---|
| NominalLength | 6mm | 8mm | 10mm | 12mm | 15mm | 18mm |
| 30mm | MSO063009 | MSO083009 | MSO103009 | MSO123009 | MSO153009 | MSO183009 |
| 30mm | MSO063018 | MSO083018 | MSO103018 | MSO123018 | MSO153018 | MSO183018 |
| 55mm | MSO065509 | MSO085509 | MSO105509 | MSO125509 | MSO155509 | MSO185509 |
| 55mm | MSO065518 | MSO085518 | MSO105518 | MSO125518 | MSO155518 | MSO185518 |
The differences between those models have been described in 012 Device Description in this 510K submission.
The proposed device shares the similar indications for use, same device operation, and overall technical and functional capabilities as the predicate device. It also has the same standards and requirements as the predicate device.
9. Description of Non-clinical Testing
The non-clinical tests of the subject device and predicate device are in compliance with the following standards and guidance.
The biocompatibility evaluation for MultiStage Balloon Dilatation Catheter was conducted in accordance with ISO 10993-1.
- Cytotoxicity (ISO 10993-5)
- · Sensitization (ISO 10993-10)
- · Intracutaneous reactivity test (ISO 10993-10)
Result: All tests were passed.
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Image /page/8/Picture/1 description: The image shows a logo for "t-MED". The logo features a stylized letter "A" in orange, with a circular shape behind it. The text "t-MED" is written in black below the "A".
Shelf life for MultiStage Balloon Dilatation Catheter test is conducted based on ASTM F1980:
• Shelf life test report
Result: All tests were passed.
Sterile barrier systems for MultiStage Balloon Dilatation Catheter were evaluated in accordance with ISO 11607-1:2019.
Sterilization Process has been validated accordance with ISO 11135:2014.
Result: The MultiStage Balloon Dilatation Catheter is sterile with a determination of the sterilization process to demonstrate achievement of the required SAL of 10° is in accordance to half cycle overkill approach.
Technological characteristics for MultiStage Balloon Dilatation Catheter have been tested for its functions as intended including verification of performance characteristics per performances characteristics relevant to functions as intended:
- Visual Inspection
- · Bacteriostasis performance of pouch
- · Dye penetration
- Pouch
- · Tension test
- · Guidewire compatibility test
- Channel compatibility
- Product Dimensional Inspection
- Compliance
- . Balloon fatigue; No leakage and damage when inflation
- Balloon inflation and deflation time .
- Balloon rated burst pressure (RBP) .
- Peak tensile
- · Leakage Test
- Hydratability
- •
- · Corrosion resistance
- · X-ray detectability
- · Torsion test
The results of Non-Clinical Performance testing demonstrate that the MultiStage Balloon Dilatation Catheter is considered safe and effective for its intended use.
10. Performance Data-Clinical
No clinical study is included in this submission.
11. Conclusion
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Image /page/9/Picture/1 description: The image shows a logo for t-MED. The logo features a stylized letter 'A' in orange, with a circular arc behind it, also in orange. Below the 'A', the text 't-MED' is written in a smaller, sans-serif font, also in orange. The overall design is simple and modern, with a focus on the letter 'A' as the central element.
It has been shown in this 510(k) submission that the differences between the proposed device and the predicate device do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed device is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.
Therefore, the proposed device is determined to be substantially equivalent to the referenced predicate device.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.