(161 days)
K/DEN number: K170059
No
The summary describes a mechanical laser atherectomy catheter and its intended use, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for "treatment, including atherectomy, of infrainguinal stenoses and occlusions," which directly describes a therapeutic application.
No
The device is described as an atherectomy catheter, which is used for treatment (removal of plaque), not for diagnosis.
No
The device description clearly describes a physical catheter with optical fibers and a guidewire lumen, indicating it is a hardware device, not software-only. The performance studies also focus on physical characteristics and validations.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a surgical procedure (atherectomy) within the body (infrainguinal and femoropopliteal arteries). IVDs are used to examine specimens taken from the body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details a physical catheter with optical fibers designed for insertion into blood vessels. This is consistent with a surgical or interventional device, not a diagnostic test performed on a sample.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter is an interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 nutinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).
Product codes
QTF
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infrainguinal
femoropopliteal artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 the symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in bold, blue letters, with the word 'ADMINISTRATION' written in a smaller font size below.
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
NES Reprocessed 0.9mm Turbo-Elite Laser Atherectomy Catheter
Indications for Use (Describe)
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).
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
The Reprocessed Device Models in scope of K220171 are as follows:
| Description | Item
Number | Guidewire
Compatibility | Max Tip
Diameter | Max Shaft
Diameter | Working
Length | Sheath
Compatibility |
|--------------------------------------------------|----------------|----------------------------|---------------------|-----------------------|-------------------|-------------------------|
| 0.9mm Turbo-
Elite Laser
Ablation Catheter | 410-152 | 0.014" | 0.038" | 0.047" | 150 cm | 4 Fr. |
4
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:
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.
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
5
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 | Guidewire
Compatibility | Max Tip
Diameter | Max Shaft
Diameter | Working
Length | Sheath
Compatibility |
|--------------------------------------------------|-------------|----------------------------|---------------------|-----------------------|-------------------|-------------------------|
| 0.9mm Turbo-
Elite Laser
Ablation 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
6
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.