(186 days)
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
The Ultravision2™ System is a multifunctional system that synchronizes visual field clearing with the activation of smoke-producing electrosurgical devices. The system interfaces with commercially available electrosurgical instruments. The Ultravision2™ Generator connects directly to a commercially available electrosurgical generator (ESU) and passes the RF energy through to the desired electrosurgical instrument connected to the Utravision2™ Generator. The Ultravison2™ System is able to automate the activation of the Ionwand for visual field clearing to the activation of the electrosurgical device to synchronize visual field clearing with the generation of smoke. The Ionwand™ pack comprises a dedicated percutaneous 3mm trocar/catheter which accommodates the Ionwand™ cable that delivers low energy from the generator to the patient. The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable. This device is for prescription use only.
The information provided does not contain a study that proves the device meets the acceptance criteria. It presents a summary of non-clinical testing performed, including acceptance criteria and results (all "Pass"), but does not detail the methodology, sample sizes, or ground truth establishment for these tests in a way that aligns with a typical performance study.
Based on the provided text, here's what can be extracted:
1. Table of acceptance criteria and the reported device performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf life | Product and package must demonstrate stability for the claimed shelf life of 5 years. | Pass |
| Software verification and validation | Device functions controlled by software must perform as intended | Pass |
| Electrical safety and electromagnetic compatibility | Device must meet the requirements of the applicable clauses in the standards (IEC 60601-1, IEC 60601-2-2, EN 60601-1-2) | Pass |
| Dimensional and physical verification of unit | Device must meet dimensional specification and physical specifications as per internal standards. | Pass |
| High voltage output | Device must deliver specified output, into required loads, at given temperatures and humidities, and for the specified product lifetime as per internal standards. | Pass |
| Generator basic function including: | Device must meet specifications for connections and functionality as per internal standards. | Pass |
| Generator safety measures including: | Must meet specifications for device function independent of software, extreme misuse, or single fault conditions as per internal standards. | Pass |
| Generator user interface hardware control | Must meet specifications for device function independent of software, extreme misuse, or single fault conditions as per internal standards. (Note: Same criterion as "Generator safety measures including:") | Pass |
| Generator high voltage power management | Must meet specifications for DC output under proximity and HVDC limit protection measure as per internal standards. | Pass |
| Generator surgical energy detection | Device must demonstrate energy detection for external ultrasonic energy as per internal standards. | Pass |
| Mechanical connections and controls | Device must demonstrate acceptable durability of link cables, fascia connections, and cable retention as per internal standards. | Pass |
| Surgical generator compatibility | Device must demonstrate compatibility with applicable generators in terms of load curve characterization, CQM performance, HF leakage, and RF detection. as per internal standards. | Pass |
| Design validation under simulated use conditions | Must demonstrate that the device can achieve its intended use when used by end users as per internal standards. | Pass |
2. Sample sized used for the test set and the data provenance:
The document summarizes "non-clinical testing" and lists various tests, but it does not specify sample sizes for any of these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature) as these are non-clinical engineering and performance characterization tests, not studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as the disclosed tests appear to be engineering and design validation tests rather than clinical studies requiring expert ground truth for interpretation (e.g., image analysis by radiologists).
4. Adjudication method for the test set:
This information is not provided for the same reasons as above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple expert readers.
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 conducted or described in the provided text. The device is a "Surgical Smoke Precipitator" and an "Ultravision2™ System" which focuses on clearing smoke during laparoscopic surgery, not an AI diagnostic or assistive device for human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The Ultravision2™ System is a medical device for surgical smoke clearance, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's function is physical and mechanical/electrical in nature for smoke precipitation synchronization.
7. The type of ground truth used:
The "ground truth" for the reported tests appears to be engineering specifications and established standards (e.g., ASTM, IEC, internal standards). For example, for "Dimensional and physical verification," the ground truth is "dimensional specification and physical specifications as per internal standards." For "Electrical safety," it's "the requirements of the applicable clauses in the standards."
8. The sample size for the training set:
This information is not applicable as the device is not an AI/machine learning system that requires a training set in the typical sense.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
October 31, 2023
Alesi Surgical Ltd % Michele Lucey Regulatory Consultant Lakeshore Medical Device Consulting, LLC 128 Blve Hill Landing Newbury, New Hampshire 03255
Re: K231238
Trade/Device Name: Ultravision2™M System Regulation Number: 21 CFR 878.5050 Regulation Name: Surgical Smoke Precipitator Regulatory Class: Class II Product Code: PQM Dated: September 25, 2023 Received: September 28, 2023
Dear Michele Lucey:
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.
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).
Sincerely.
Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical
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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) K231238
Device Name Ultravision2™ System
Indications for Use (Describe)
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
| 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/4/Picture/0 description: The image contains the logo for Alesi Surgical. The logo consists of three curved shapes in different shades of blue and purple on the left side. To the right of the shapes is the word "alesi" in a dark blue sans-serif font, with the word "surgical" in a smaller, lighter blue font underneath.
K231238
510(K) SUMMARY TRADITIONAL As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | Alesi Surgical Ltd |
|---|---|
| Address: | Cardiff Medicentre |
| Heath Park | |
| Cardiff | |
| CF14 4UJ | |
| UK | |
| Telephone: | +44 (0) 2920291022 |
| Fax: | +44 (0) 2920750239 |
| Contact Person: | Michele Lucey |
| Lakeshore Medical Device Consulting LLC. | |
| 128 Blye Hill Landing. | |
| Newbury, | |
| New Hampshire 03255 | |
| Telephone: | 603-748-1374 |
| Date Prepared: | October 31, 2023 |
| Device Proprietary Name: | Ultravision2™ System |
| Common Name: | Surgical Smoke Precipitator |
| Classification Name: | Surgical Smoke Precipitator |
| Classification Regulation: | 21 CFR 878.5050 |
| Regulatory Class: | Class II |
| Product Code(s): | PQM |
| Predicate Device: | Ultravision™ Visual Field Clearing System (K200035) |
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Indications for Use:
The Ultravision2™ System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision2™ 5mm Trocar component establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision2™ Generator interfaces directly with the electrosurgical generator and serves as a pass-through for RF energy to RF electrosurgical instruments.
Device Description/Technological Characteristics:
The Ultravision2™ System is a multifunctional system that synchronizes visual field clearing with the activation of smoke-producing electrosurgical devices. The system interfaces with commercially available electrosurgical instruments. The Ultravision2™ Generator connects directly to a commercially available electrosurgical generator (ESU) and passes the RF energy through to the desired electrosurgical instrument connected to the Utravision2™ Generator. The Ultravison2™ System is able to automate the activation of the Ionwand for visual field clearing to the activation of the electrosurgical device to synchronize visual field clearing with the generation of smoke. The Ionwand™ pack comprises a dedicated percutaneous 3mm trocar/catheter which accommodates the Ionwand™ cable that delivers low energy from the generator to the patient. The Ultravision™ 5mm Trocar includes a dedicated Ionwand™ cable. This device is for prescription use only.
| Model # | Component Description |
|---|---|
| DPD-006-001 | Ultravision2™ System, including:• Standalone generator• Link cables (x4)• Equipotential cable• Power cable |
| DAD-001-003 | Ionwand Pack, including:• Stainless steel active cable the “Ionwand™”• Trocar/catheter assembly |
| DAD-003-013 | Ultravision 5mm Trocar, including:• 5mm trocar• Ionwand cable assembly |
The components of the system are described as follows:
Technological Characteristics Comparison:
The comparison table below provides the similarities and differences between the predicate and subject devices. The modifications made to the subject device do not raise any risk to safety or effectiveness.
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| Feature/Specification | Ultravision2TM System | UltravisionTM Visual FieldClearing System | Comparison |
|---|---|---|---|
| RegulatoryClearance/ApprovalReference | K231238Subject Device | K200035Predicate Device | N/A |
| Product Code(s) | PQM | PQM | Equivalent |
| RegulationNumber(s) | 21 CFR 878.5050 | 21 CFR 878.5050 | Equivalent |
| RegulationName(s) | Surgical Smoke Precipitator | Surgical Smoke Precipitator | Equivalent |
| Where used(environment) | Operating Room | Operating Room | Equivalent |
| Anatomical Sites | Abdominal and pelviccavity | Abdominal and pelviccavity. | Equivalent |
| Target population | General patients requiringelectrosurgery in a hospitalsetting | General patients requiringelectrosurgery in a hospitalsetting | Equivalent |
| Mechanism ofAction for VisualField Clearing | Electrostatic precipitation ofsmoke to clear the visualfield during laparoscopicsurgical procedures | Electrostatic precipitation ofsmoke to clear the visualfield during laparoscopicsurgical procedures | Equivalent |
| Generator outputSmokePrecipitation | 9.8KV dc | 9.8KV dc | Equivalent |
| Current | Ionwand- intermittent max20μA | Continuous max 10μA | SimilarThis difference does notraise new questions ofsafety and effectiveness.,confirmed by electricalsafety testing |
| Ionwand tipmaterial | Implant grade Stainlesssteel, annealed | Implant grade Stainless steel,annealed. | Equivalent |
| Ionwand tipexposed length | 4.0mm | 4.0mm | Equivalent |
| Ionwand insulationwall thickness | 0.7mm | 0.7mm | Equivalent |
| Plug and cablelength | 2.5mm | 2.5mm | Equivalent |
| Ionwand energymodality | HVDC | HVDC | Equivalent |
| Ionwand workinglength | 109mm | 109mm | Equivalent |
| Mechanism ofaction of visualfield clearance | Electrostatic precipitation | Electrostatic precipitation | Equivalent |
| Generator smokeclearing activation. | Automatic on/off timedoutput triggered by energydetection or user selection(manual button press ongenerator) | Continuous output untilswitched off on generator | Different, results in lessactivation of the Ionwandduring the procedure. Thisdifference does not raisenew questions about safetyand effectiveness |
| Feature/Specification | Ultravision2™ System | Ultravision™ Visual FieldClearing System | Comparison |
| GeneratorCompatibility toElectrosurgicalEnergy Input | Commercially availableElectrosurgical generators,Monopolar, and Bipolarenergy input | NA | Compatibility andelectrical safety is shownthrough performancetesting. This differencedoes not raise newquestions about safety andeffectiveness. |
| GeneratorCompatibility toHandpiece | Universal compatibility formonopolar and bipolarenergy types | NA | Compatibility is shownthrough safety andperformance testing. Thisdifference does not raise newquestions about safetyand effectiveness. |
| 5mm IonWandtrocar material | Thermoplastic | Thermoplastic | Equivalent |
| Retention features | Ribbed | Micro- ridges | Different, results inimproved retention of thetrocar during theprocedure. This differencedoes not raise newquestions about safety andeffectiveness |
| Type of sealingemployed | Duckbill valve and separateseal | Duckbill valve and separateseal | Equivalent |
| Valve and sealmaterial | Elastomer | Elastomer | Equivalent |
| Software Controls | Software is not a riskcontrol. Provides an audio-visual indication if theIonWand is touching tissueor a metallic instrument(output is timed with apredetermined shut-offtherefore this is notconsidered to be an alarm) | Software is a risk controlproviding an audio-visualalarm if the IonWand istouching tissue or a metallicinstrument (required as theoutput is continuous oncemanually turned on at thegenerator) | Different, UV2 has apredetermined timedoutput which is controlledby hardware only. Thus,software has no role inenergy output and is notconsidered to be a riskcontrol. This differencedoes not raise newquestions of safety andeffectiveness. |
| Software SafetyClassification/Level of Concern | Minor Level of Concern(Basic documentation)Class A per IEC 62304 | Moderate Level of Concern(Category 2)Class B per IEC 62304 | Different, the reduction insafety concerns comparedto the predicate does notraise new questions ofsafety and effectiveness |
| ApplicableElectrical SafetyStandards | IEC 60601-1ISO 60601-1-6IEC 60601-2-2 | IEC 60601-1ISO 60601-1-6IEC 60601-2-2 | Equivalent |
| ApplicableElectromagneticCompatibilityStandards | IEC 60601-1-2 | IEC 60601-1-2 | Equivalent |
| ApplicableSoftwareStandards | IEC 62304 | IEC 62304 | Equivalent |
| Feature/Specification | Ultravision2TM System | UltravisionTM Visual FieldClearing System | Comparison |
| Biocompatibility | Meets ISO 10993 | Meets ISO 10993 | Equivalent |
| Sterilization | EtO, validated per ISO11135 | EtO, validated per ISO11135 | Equivalent |
| Sterility AssuranceLevel | 10-6 | 10-6 | Equivalent |
| How Supplied(single use) | Ionwand and trocar -supplied sterile in singleblister pack or pouch | Ionwand, trocar -suppliedsterile in single blister orpouch | Equivalent |
Technological Characteristics Comparison Table
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Summary of Non-clinical Testing:
Testing demonstrated acceptable device performance for the device's intended use. System and software verification and validation activities were successfully completed.
| TestPerformed | Standard Followed | Acceptance Criteria | TestResults |
|---|---|---|---|
| Shelf life | ASTM F1980-16 StandardGuide for Accelerated Agingof Sterile Medical DevicePackages | Product and package must demonstratestability for the claimed shelf life of 5 years. | Pass |
| ASTM 2096 Standard TestMethod for Detecting GrossLeaks in Packaging byInternal Pressurization | |||
| ASTM F1929-15 StandardTest Method for DetectingSeal Leaks in Porous MedicalPackaging by Dye Penetration | |||
| ASTM F88/F88M -15Standard Test Method for SealStrength of Flexible BarrierMaterials | |||
| Software verificationand validation | IEC62304 2006+A1:2015Medical Device Software –Software Life Cycle Process | Device functions controlled by software mustperform as intended | Pass |
| Electrical safety andelectromagneticcompatibility | IEC 60601-1 MedicalElectrical Equipment,Edition 3.1, which is Edition3.0 (2005-12) as modified byAM1 (2012-07) evaluation. | Device must meet the requirements of theapplicable clauses in the standards | Pass |
| IEC 60601-2-2 HighFrequency SurgicalEquipment (2017-03)evaluation | |||
| EN 60601-1-2:2015 +A1:2021 Medical electricalequipment General | |||
| TestPerformed | Standard Followed | Acceptance Criteria | TestResults |
| requirements for basic safetyand essential performance.Collateral Standard:Electromagnetic disturbances | |||
| Dimensionaland physicalverificationof unit | NA | Device must meet dimensional specificationand physical specifications as per internalstandards. | Pass |
| High voltage output | NA | Device must deliver specified output, intorequired loads, at given temperatures andhumidities, and for the specified productlifetime as per internal standards. | Pass |
| Generator basicfunction including: | NA | Device must meet specifications forconnections and functionality as per internalstandards. | Pass |
| Generator safetymeasures including: | NA | ||
| Generator userinterfacehardware control | NA | Must meet specifications for device functionindependent of software, extreme misuse, orsingle fault conditions as per internalstandards. | Pass |
| Generator highvoltage powermanagement | NA | Must meet specifications for DC output underproximity and HVDC limit protection measureas per internal standards. | Pass |
| Generator surgicalenergy detection | NA | Device must demonstrate energy detection forexternal ultrasonic energy as per internalstandards. | Pass |
| Mechanicalconnections andcontrols | NA | Device must demonstrate acceptable durabilityof link cables, fascia connections, and cableretention as per internal standards. | Pass |
| Surgical generatorcompatibility | NA | Device must demonstrate compatibility withapplicable generators in terms of load curvecharacterization, CQM performance, HFleakage, and RF detection. as per internalstandards. | Pass |
| Design validationunder simulated useconditions | NA | Must demonstrate that the device can achieveits intended use when used by end users as perinternal standards. | Pass |
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Biocompatibility
The tissue contacting components of the Ultravision2™ System are identical and process to the previously cleared devices. No additional biocompatibility testing was performed.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, K231238 is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200035, Class II (21 CFR 878.5050), product code PQM.
§ 878.5050 Surgical smoke precipitator.
(a)
Identification. A surgical smoke precipitator is a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Adverse tissue reaction must be mitigated through the following:
(i) Chemical characterization and toxicological risk assessment of the treated surgical smoke.
(ii) Demonstration that the elements of the device that may contact the patient are biocompatible.
(2) Electrical safety and electromagnetic compatibility testing must demonstrate that the device performs as intended.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Performance data must demonstrate the sterility of the patient contacting components of the device.
(5) Performance data must support the shelf life of the sterile components of the device by demonstrating continued functionality, sterility, and package integrity over the identified shelf life.
(6) Animal simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Device must be demonstrated to be effectively inserted, positioned, and removed from the site of use.
(ii) Device must be demonstrated to precipitate surgical smoke particulates to clear the visual field for laparoscopic surgeries.
(iii) Device must be demonstrated to be non-damaging to the site of use and animal subject.
(7) Labeling must identify the following:
(i) Detailed instructions for use.
(ii) Electrical safety and electromagnetic compatibility information.
(iii) A shelf life.