The Tenex® 2nd Generation System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of both soft and hard (e.g.: bone) tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery, and Plastic and Reconstructive Surgery.

The Tenex® 2nd Generation System is also indicated for use in the debridement of wounds, such as, but not limited to diabetic ulcers, in application, in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.

Device Description

The Tenex 2nd generation system is an ultrasonic surgical instrument that fragments, emulsifies and aspirates soft and hard tissue. It also provides sharp debridement of soft and hard tissue in wounds such as neuropathic diabetic ulcers. The Tenex 2nd generation system is intended for use in an office-based setting, clinical or hospital environment. The system consists of a Console, ultrasonic MicroTips, a Foot Switch and a number of accessories.

The Console includes a touch screen tablet with a graphical user interface, motors to drive diaphragm pumps in the MicroTip, ultrasonic driver electronics and Software. The Console generates the ultrasonic energy required to operate the MicroTips and manages irrigation fluids. The Console is non-sterile when used and does not require processing.

The MicroTips connect to the Console for electrical power and to facilitate the transfer of irrigation fluid from the saline bag to the surgical site, and then aspirate the emulsified tissue and fluid to a collection bag incorporated into single use, disposable the MicroTip assembly. Motors in the Console couple to the diaphragm pumps in the MicroTips to control the fluid flows. The MicroTips are constructed from various biocompatible polymers and metals. The MicroTip tubing is made of biomedical grade PVC and silicone.

The MicroTips are single use and sterile packaged. They are sterilized via gamma irradiation. The MicroTips are the ultrasonic surgical hand pieces that house the transducers, horns and needles with beveled tips.

The Foot Switch is used by the user to remotely control the Console. It connects to the back of the Console via an electrical cable. It provides on/off functionality for cutting, irrigation, and aspiration. The Foot Switch is IPX8 rated for protection against liquids.

The System includes additional components. a Packaging Hard Case is provided for shipping, handling. and storage of the Console, and a power cord is provided for connecting the Console to facility electrical power to operate the device. These items are non-sterile when used and do not require processing.

Associated accessories include: a USB Flash Drive for saving procedure information, USBC-HDMI cable for connecting to an external display, and a USB-Smartphone adaptor for connecting USB output to a smartphone.

AI/ML Overview

The provided text is a 510(k) summary for the Tenex® 2nd Generation System, an ultrasonic surgical instrument. It details the device's characteristics, intended use, and non-clinical performance testing. However, it does not include specific acceptance criteria or a study that directly proves the device meets those criteria in a format allowing a table of acceptance criteria vs. reported performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Tenex Health TX System with the TXP MicroTip, K181367) through a comparison of technical characteristics and non-clinical performance testing against various standards.

Here's an attempt to extract and interpret the requested information based on the provided text, while noting what is not present:

Missing Information in the Provided Text:

Specific Quantitative Acceptance Criteria: The document describes types of tests performed (e.g., Aspiration, Irrigation, MicroTip strength) and mentions the system "met requirements" or "met the standards," but it does not specify the quantitative performance metrics (e.g., "Aspiration volume must be >X cc/min" or "MicroTip strength must withstand Y force").
Reported Device Performance against specific criteria: Without specific acceptance criteria, corresponding reported device performance against those criteria cannot be tabulated directly.
Detailed Study Protocol for Performance Evaluation: The text lists various non-clinical performance tests but does not provide details of a single, comprehensive study with a defined sample size, ground truth, or expert involvement to "prove" the device meets acceptance criteria in a comparative sense.
Sample size for test set with data provenance: While "simulated use testing in bovine tissue" and "simulated use testing in cadaver" are mentioned, the specific sample sizes for these tests are not provided. Data provenance is implied to be laboratory/simulated.
Number of experts and qualifications for ground truth: Not mentioned, as the focus is on engineering and standard compliance rather than clinical interpretation.
Adjudication method: Not applicable as no expert review process for ground truth is described.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned and not likely relevant for a device of this type, which is a surgical instrument rather than an AI-powered diagnostic tool.
Standalone (algorithm-only) performance: Not mentioned. The device's software is for control and interface, not for standalone diagnostic or analytical performance.
Type of ground truth used: For the non-clinical tests, the "ground truth" would be the known physical properties and performance characteristics of the materials and systems under test, not clinical outcomes or pathology.
Sample size for training set: Not applicable, as this is not an AI/ML device in the context of a training set for a diagnostic algorithm.
How ground truth for training set was established: Not applicable.

Extracted Information (with caveats):

1. A table of acceptance criteria and the reported device performance

As noted, explicit quantitative acceptance criteria are not provided. The document states that the Tenex® 2nd Generation System "met all specified performance requirements" and "adheres to industry standards." The table below attempts to infer criteria based on the comparisons made with the predicate device and the non-clinical tests.

Characteristic / Test	Acceptance Criteria (Inferred from comparisons & standards)	Reported Device Performance
Operational Specs (compared to predicate)
Cutting levels	User selected: low, medium, and high (updated ultrasonic driver)	Met stated levels, enhanced control of power/acoustics
Irrigation flow control	User controllable, forced delivery of saline from external bag	Enhanced to stabilize flow rate, using fluid pump
Irrigation flow rates	In excess of 60 cc/min (enhanced from >30 cc/min)	In excess of 60 cc/min
Aspiration flow control	User controllable, suction provided by vacuum pump	Enhanced pump
Aspiration flow rates	User selectable, 3 levels between 100-200 cc/min (enhanced from 10-30 cc/min)	User selectable, 3 levels between 100-200 cc/min
Aspiration potential (vacuum pressure)	User selectable, 3 levels between 0-520 mmHg (enhanced from 100-500 mmHg)	User selectable, 3 levels between 0-520 mmHg
MicroTip Case Nose	Biocompatible polymer over-molding (e.g., ABS)	ABS over-molded stainless-steel sheath
Tip diameters	Multiple, between 1.5 - 1.9mm (improved strength/durability)	Between 1.5 - 1.9mm
Tip lengths	Multiple, between 1.0 - 3.0 in (improved depth of reach)	Between 1.0 - 3.0 in
User Interface	Color touchscreen, higher resolution, greater processing power	Color touchscreen (internal MS Tablet), higher resolution, greater processing power
Software/Firmware	Improved programming, display, and interface options with current technology	Windows OS; interfaces with firmware on DSP Microcontroller
Ultrasonic driver	Digital Voltage and Frequency Controlled (enhanced control of power/acoustics)	Digital Voltage and Frequency Controlled
Non-Clinical Performance Tests
Electro-mechanical bench testing	System met requirements for listed functions (Aspiration, Irrigation, MicroTip strength, etc.)	Met all requirements for: Aspiration, Irrigation, Cassette attachment/detection, Console functions, Console life cycle, Environmental ops, Hardware verification, MicroTip functions, MicroTip strength, Transit conditions.
EMC and electrical safety testing	Compliance with IEC 60601-1:2005+A1:2012+A2:2020 and IEC 60601-1-2:2014+A1:2021	Met all standards.
Software V&V	Compliance with IEC 62304:2006/A1:2016	Developed, verified, and validated per standard.
Biocompatibility evaluation	Compliance with ISO 10993-1:2018	Met standard.
Sterilization validation	Compliance with ISO 11137-1, ISO 11137-2	Met standards.
Packaging & Shelf Life Validation	Compliance with ISO 11607-1, ISO 11607-2	Met standards.
Simulated use testing (bovine tissue)	System performance and durability in tissue validated.	System performance and durability validated.
Simulated use testing (cadaver)	System design and usability validated, compliance with IEC 60601-1-6, ANSI AAMI IEC 62366-1	Design and usability validated.

2. Sample sized used for the test set and the data provenance

Sample Size: Not explicitly stated for any of the non-clinical tests (e.g., number of bovine tissue samples, number of cadavers, or number of units tested for electro-mechanical benchmarks).
Data Provenance: The data originates from internal non-clinical performance testing conducted by the manufacturer (Trice Medical, Inc.), involving simulated environments (bovine tissue, cadaver) and laboratory bench tests. Implied to be prospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts/Qualifications: Not specified. For this type of device, ground truth for bench testing refers to engineering specifications and standard compliance, not clinical expert consensus. For usability testing (simulated use in cadaver), it implies evaluation by users (e.g., surgeons), but specific numbers or qualifications are not provided.

4. Adjudication method for the test set

Adjudication method: Not applicable/not described as there isn't a stated panel review process for establishing ground truth in the context of this submission. The tests are against predefined engineering and regulatory standards.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic imaging software or AI tools, not for a surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: No, a standalone (algorithm only) performance study was not conducted. The software in the Tenex® 2nd Generation System operates the device and interfaces with the user, it does not perform an independent function that would require "standalone" performance evaluation in the context of diagnostic AI.

7. The type of ground truth used

Type of Ground Truth: For the non-clinical performance tests, the "ground truth" is based on:
- Engineering specifications and requirements: For electro-mechanical bench testing, software V&V.
- International standards: For EMC, electrical safety, biocompatibility, sterilization, packaging, and shelf-life validation.
- Expected physical and functional performance: For simulated use testing in bovine tissue and cadaver, validating that the device performs its intended functions (fragmentation, emulsification, aspiration) effectively and is usable.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is an electromechanical surgical instrument with controlling software, not an AI/ML diagnostic system that requires a "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 18, 2024

Trice Medical, Inc. David Vancelette VP of Quality Assurance & Regulatory Affairs 40 General Warren Blvd. Suite 100 Malvern, Pennsylvania 19355

Re: K241700

Trade/Device Name: Tenex 2nd Generation System Regulatory Class: Unclassified Product Code: LFL Dated: June 11, 2024 Received: June 13, 2024

Dear David Vancelette:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Long H. Chen-S Digitally signed by Long H.Chen-S
Date: 2024.11.18 15:01:04 -05'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K241700

Device Name Tenex® 2nd Generation System

Indications for Use (Describe)

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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K241700

510(k) Summary

Date:	November 7, 2024
Owner:	Trice Medical, Inc.40 General Warren Blvd.Suite 100Malvern, PA 19355 USAPhone: (610) 989-8080www.tricemedical.com
Contact Person:	David VanceletteVice President of Quality Assurance & Regulatory AffairsP: 949-238-8220E: dvancelette@tricemedical.com
Type of 510(k) Submission:	Traditional
Trade Name:	Tenex® 2nd Generation System
Common Name:	Ultrasonic Surgical Instrument
Classification Name:	Instrument, Ultrasonic Surgical
Device Class:	Unclassified
Panel:	General & Plastic Surgery
Product Code:	LFL
Predicate Devices:	K181367, Tenex Health TX System with the TXP MicroTip, ProductCode: LFL

Device Description:

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various biocompatible polymers and metals. The MicroTip tubing is made of biomedical grade PVC and silicone.

Intended Use / Indications for Use:

Technical Characteristics (Compared to Predicate):

The subject and predicate devices are ultrasonic surgical instruments that use electrical energy in the ultrasonic frequency range to drive an applicator needle for the fragmentation and emulsification of diseased tissue. The systems use irrigation with the needle at the treatment site to emulsify the fragmented tissue. The systems also use aspiration to remove the fragmented and emulsified material from the treatment site.

Characteristic	Subject DeviceTenex® 2nd GenerationSystem	Predicate DeviceTenex Health TX Systemwith TXP MicroTip(K181367)
Energy source	100-240V 50/60Hz	Same
Fragmentation/Emulsification	Ultrasonic energy	Same
Vibration system	Piezoelectric	Same
Frequency	26.5 ±1.5kHz	Same
Aspiration	Vacuum	Same

The following technological characteristics are identical for the subject and predicate device:

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K241700

Characteristic	Subject DeviceTenex® 2nd GenerationSystem	Predicate DeviceTenex Health TX Systemwith TXP MicroTip(K181367)
Irrigation	Forced	Same
System Control	Foot switch	Same
MicroTip Horn/Needle	One-piece, stainless steel	Same
Tip sheaths	Stainless steel sheath	Same
Reusable SystemComponents	Console and Foot Switch	Same

The following technological characteristics of the subject device and predicate were compared and found to have differences which do not affect the mode of operation:

Characteristic	Subject DeviceTenex® 2nd GenerationSystem	Predicate DeviceTenex Health TXSystem (K181367)	Comparison
Cutting levels	User selected: low,medium and high	Same	Updated ultrasonic driver
Irrigation flowcontrol	User controllable, forceddelivery of saline froman external saline bag	Same	Using a fluid pump insteadof a pressure cuff
Irrigation flow rates	In excess of 60 cc/min	In excess of 30 cc/minwith a full 1000cc salineirrigation bag.	Enhanced to stabilize flowrate
Aspiration flowcontrol	User controllable, suctionprovided by a vacuumpump	Same	Enhanced the pump
Aspiration flow rates	User selectable, 3 levelsbetween 100-200 cc/min	User selectable, 3 levelsbetween 10-30 cc/min	Enhanced to improveocclusion prevention andremoval
Aspiration potential(vacuum pressure)	User selectable, 3 levelsbetween 0 - 520mmHg	User selectable, 3 levelsbetween 100 - 500mmHg	Enhanced to improve timeto vacuum pressure andocclusion prevention.
Aspiration WasteContainer	1000cc sterile collectionbag integrated into theMicroTip	1000cc sterile collectionbag integrated into theMicroTip	Subject device incorporatesadditional filtration.
MicroTip Case Nose	ABS over-moldedstainless-steel sheath	Polycarbonate over-molded stainless-steelsheath	Both have equivalentbiocompatible polymerover-molding
Tip diameters	Multiple MicroTips,between 1.5 - 1.9mm(.059 - .074 in)	Multiple MicroTips,between 1.1 - 1.9mm(.042 - .074 in)	Improved tip strength anddurability.
Tip lengths	Multiple MicroTips,between 1.0 - 3.0 in	Multiple MicroTips,between 1.0 - 2.0 in	Improved depth of reach.

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K241700

Characteristic	Subject DeviceTenex® 2nd GenerationSystem	Predicate DeviceTenex Health TXSystem (K181367)	Comparison
Single-Use, SterileComponents	MicroTips	MicroTipsSupply Kit	Convenience kit removed
User Interface	Color touchscreen,component of an internalMS Tablet	Color touchscreen,connected to the internalcomputer.	Higher resolution, greaterprocessing power for moredisplay and interfacefeatures.
Software/Firmware	Windows OperatingSystem runningApplication Software onTouch Screen Tablet,interfaces with Firmwareon DSP Microcontroller	Linux Operating Systemrunning ApplicationSoftware on ARMMicroprocessor	Improved programming,display and interfaceoptions with currenttechnology
Ultrasonic driver	Digital Voltage andFrequency Controlled	Analog FrequencyControlled	Enhanced control of powerand acoustics

Non-Clinical Performance Data:

The following non-clinical performance tests were conducted to evaluate differences noted above and demonstrate substantial equivalence to the predicate device:

1. Electro-mechanical bench testing verified that the system met requirements for:
- Aspiration
- Irrigation ●
- Cassette attachment and detection ●
- Console functions ●
- Console life cycle
- Environmental operating conditions
- Hardware verification
- MicroTip functions ●
- . MicroTip strength
- Transit conditions

EMC and electrical safety testing verified the system met the standards:

IEC 60601-1:2005+A1:2012+A2:2020 / Edition 3.2 2020-08 Consolidated Version, Medical . electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014+A1:2021, Medical electrical equipment Part 1-2: General requirements . for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
1. Software Verification & Validation ...

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Software was developed, verified and validated per IEC 62304:2006/A1:2016, Medical device ● software - Software life cycle processes
1. Biocompatibility evaluation verified the system met the standard: ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
1. Sterilization validation of the sterile packaged MicroTip showed the device met the standards:
- . ISO 11137-1 Third edition 2018-01 [Including AMD1:2021], Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2 Third edition 2013-06 [Including AMD1:2022], Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
1. Packaging & Shelf Life Validation of the sterile packaged MicroTip showed the device met the standards:
- . ISO 11607-1 Second edition 2019-02 [Including AMD1:2023], Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2 Second edition 2019-02, Packaging for terminally sterilized medical devices Part ● 2: Validation requirements for forming, sealing and assembly processes
1. Simulated use testing in bovine tissue
- Validated the system's performance and durability in tissue. ●
1. Simulated use testing in cadaver validated the system's design and usability.
- . Usability Validation per IEC 60601-1-6 Edition 3.2 2020-07 Consolidated Version, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability, and:
- ANSI AAMI IEC 62366-1:2015+AMD1:2020 Medical devices Part 1: Application of usability . engineering to medical devices, including Amendment 1
- . Cadaveric design validation of the device in a simulated surgical setting for its Indications for Use.

Conclusions:

The Tenex® 2ªd Generation System met all specified performance requirements. The non-clinical data, including the simulated use testing results, demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device. Evaluation did not raise any new questions regarding safety and effectiveness. The Tenex® 2nd Generation System is determined to be substantially equivalent to the predicate device.

Regulation Number and Section

N/A