The NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter (0.014" guidewire compatible and over-the-wire configuration) is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.

The 0.014" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nutinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Device Description

The NES Reprocessed Spectranetics Turbo-Elite Laser Catheters are percutaneous intravascular devices constructed of multiple optical fibers arranged around a guidewire lumen. Catheter sizing identification is printed on the catheters.

For NES Reprocessed Spectranetics Turbo-Elite Laser Catheters, Over-The-Wire (OTW) catheters, a Luer adapter located at the proximal end of the usable length facilitates the use of the laser catheter over the appropriately sized guidewire.

AI/ML Overview

This document describes the NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter and its substantial equivalence to a predicate device, focusing on functional and safety testing rather than an AI/ML device. Therefore, many standard questions about acceptance criteria and studies for AI/ML devices (e.g., sample sizes for test/training sets, expert consensus, MRMC studies) are not applicable in this context.

However, I can extract the acceptance criteria and the type of studies performed to demonstrate the device's safety and effectiveness.

1. Table of Acceptance Criteria (from the perspective of a reprocessed medical device) and Reported Device Performance:

Acceptance Criteria Category	Specific Criterion / Test Performed	Reported Device Performance / Conclusion
Reprocessing Effectiveness	Cleaning Validation	Demonstrated effective cleaning.
	Sterilization Validation	Demonstrated effective sterilization.
	Drying Validation	Demonstrated effective drying.
	Reprocessing Cycle Limit Enforcement (1 cycle max)	Device is reprocessed no more than once; marked and rejected from further reprocessing after this limit.
	Restriction on Reprocessing Devices from Other Reprocessors	Northeast Scientific restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Device Integrity & Functionality	Visual Inspection	Inspected prior to packaging and labeling. (Implies meeting visual quality standards for a reprocessed device.)
	Dimensional Verification	Verified prior to packaging and labeling. (Implies meeting specified dimensional tolerances.)
	Mechanical Characteristics (e.g., integrity, strength)	Tested to ensure maintained mechanical properties after reprocessing.
	Hydrophilic Coating (application & performance)	Proprietary lubricious hydrophilic coating applied to facilitate movement through arteries. (Implies meeting performance standards for lubricity.)
	System Compatibility (with Spectranetics CVX-300 Excimer Laser)	Tested to ensure continued compatibility with the specified laser system.
	Solarization (related to laser energy transmission degradation)	Tested. (Implies meeting standards for maintaining acceptable laser energy transmission.)
	Tissue Ablation (effectiveness of laser function)	Tested. (Implies demonstrated ability to photoablate lesions effectively.)
Biocompatibility	Biocompatibility Testing	Demonstrated acceptable biocompatibility for patient contact.
Packaging Integrity	Packaging Validation	Demonstrated effective packaging to maintain sterility and device integrity.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the given text. For a reprocessed medical device, the "test set" would typically refer to the number of devices subjected to each specific functional and safety test (e.g., how many catheters were used for cleaning validation, how many for tissue ablation testing, etc.) and the number of reprocessing cycles they underwent. The provenance would be the manufacturing facility of Northeast Scientific, Inc., and the studies would be prospective bench and laboratory tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm requiring expert interpretation to establish ground truth. The "ground truth" for this device is established through physical and chemical measurements, functional performance, and biological safety testing against established standards.

4. Adjudication Method for the Test Set:

This is not applicable for a physical medical device. Decisions are based on objective measurements and compliance with predetermined specifications and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms where human reader performance is being evaluated with and without AI assistance. This document describes a physical laser atherectomy catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this reprocessed device is established through:

Engineering specifications and design requirements: For dimensional checks, mechanical characteristics, and system compatibility.
Chemical and microbiological standards: For cleaning, sterilization, and biocompatibility validations.
Performance metrics: For hydrophilic coating efficacy, solarization, and tissue ablation effectiveness, compared against the original predicate device's performance or established clinical benchmarks.
Regulatory standards: All testing is performed to meet FDA and international standards for medical devices.

8. The Sample Size for the Training Set:

This is not applicable as the document is for a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of reprocessed medical devices; rather, there are manufacturing and process validation runs.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable. As mentioned above, there is no "training set" for this type of device. The ground truth for validating the reprocessing process and the final device's performance is based on established engineering principles, scientific standards, and regulatory requirements specific to medical device manufacturing and reprocessing.

Summary

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July 1, 2022

Northeast Scientific, Inc. Matthew Farley Director of Engineering 2142 Thomaston Ave. Waterbury, Connecticut 06704

Re: K220171

Trade/Device Name: NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II Product Code: QTF Dated: June 3, 2022 Received: Jume 6, 2022

Dear Matthew Farley:

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

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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 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 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,

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K220171

Device Name

NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter

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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The Reprocessed Device Models in scope of K220171 are as follows:

Description	ItemNumber	GuidewireCompatibility	Max TipDiameter	Max ShaftDiameter	WorkingLength	SheathCompatibility
0.9mm Turbo-Elite LaserAblation Catheter	410-152	0.014"	0.038"	0.047"	150 cm	4 Fr.

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510(k) SUMMARY

As required by 21 CFR 807.92(c)

Submitter's Name and Address:

Northeast Scientific, Inc. (NES) 2142 Thomaston Ave. Waterbury, CT 06704

Contact Name and Information:

Matt Farley Director of Engineering Northeast Scientific, Inc. 203-756-2111 (office) 203-757-5532 (fax) matt@smarthealth-care.com

Date Prepared:

December 10th, 2021

Device Information:

Trade/Proprietary Name:	NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
Common or Usual Name:	Laser Atherectomy Catheter
Classification Name:	Intraluminal Artery Stripper
Classification Number:	Class II, 21 CFR 870.4875
Product Code:	QTF
510k Number:	K220171

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K170059	Spectranetics Turbo-Elite Laser Atherectomy Catheters	Spectranetics/Philips

Table 5.1 – Predicate Device

Device Description:

Mechanism of Action for Turbo-Elite Catheters:

The multifiber laser catheters transmit ultraviolet energy from the Spectranetics CVX-300 Excimer Laser to the obstruction in the artery. The ultraviolet energy is delivered to the laser catheter to photoablate lesions which may be compromised of atheroma, fibrosis, calcium, and thrombus; thus, recanalizing diseased vessels (photoablation is the process by which energy photons cause molecular

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bond disruption at the cellular level without thermal damage to surrounding tissue). The Spectranetics laser catheters have a proprietary lubricious coating to ease their trackability through arteries.

Description	Item Number	GuidewireCompatibility	Max TipDiameter	Max ShaftDiameter	WorkingLength	SheathCompatibility
0.9mm Turbo-Elite LaserAblation Catheter	410-152	0.014"	0.038"	0.047"	150 cm	4 Fr.

The item numbers in scope of this submission are as follows:

Table 5.2 – Device Scope

Indications for Use:

The NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter (0.014″ guidewire compatible and over-the- wire configuration) is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. The 0.014" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).

Technological Characteristics:

The purpose, design, function, and intended use of the reprocessed catheter are identical to the predicate devices. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Northeast Scientific's reprocessing of the catheter includes removal of visible soil and decontamination. Northeast Scientific also applies a proprietary lubricious hydrophilic coating to facilitate movement through the arteries. Each device is inspected and functionally tested prior to packaging and labeling.

Functional and Safety Testing:

Bench and laboratory testing was conducted to demonstrate (safety and effectiveness) of the NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter. This included the following:

Cleaning Validation
Sterilization Validation
. Functional testing
- Visual Inspection O
- Dimensional Verification O
- Simulated Use O
- Mechanical Characteristics O
- Hydrophilic Coating O
- O System Compatibility
- Solarization O
- O Tissue Ablation
Drying Validation
Packaging Validation
Biocompatibility

The catheter is reprocessed no more than one (1) time. Each device is marked during reprocessing. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further

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reprocessing. Reprocessing is performed only by Northeast Scientific. Northeast Scientific restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Conclusion:

Northeast Scientific, Inc. concludes that the NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter is substantially equivalent to the predicate devices described herein.

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).