(83 days)
Not Found
Not Found
No
The document describes a fiber delivery system and contact tips for laser surgery, focusing on the physical components and their function in transmitting laser energy. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device's description states its purpose is to "achieve the treatment of the disease" by transmitting laser energy to a diseased area, which explicitly indicates a therapeutic function.
No
The device is described as a fiber delivery system and contact tips intended for surgical procedures to achieve "incision, excision, vaporization of tissue" by transmitting laser energy to the diseased area for treatment. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is a "transmission path for 810mm, 980mm wavelength laser generator to the surgical site, with the optical fiber as the propagation medium," and mentions physical components like "metal connector" and "contact laser tread," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in general surgery and various surgical specialties to achieve tissue effects like incision, excision, and vaporization. This describes a device used on the patient's body for treatment, not a device used to examine specimens from the body to diagnose a condition.
- Device Description: The description explains that the device is a transmission path for laser energy to a surgical site to treat diseased areas. This further reinforces its role as a surgical tool.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Performing tests in vitro (outside the body)
The device is a surgical laser fiber delivery system, which is a therapeutic device used during surgical procedures.
N/A
Intended Use / Indications for Use
The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the tsue effects of incision, vaporizationand coagulation of tisue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905connector.
·Laser must operate at a wavelength between 532 and 1064 nm.
-
- Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.
·Laser must have a numerical aperture of 0.35 or less.
- Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.
- Laser must accept universal SMA-905 connector, or an appropriate adapter into its fiber launch connector. Note: These Fiber Delivery Systems are cleared for use for the laser system to which they are connected. During use these products are exposed to biohazardous such as blood and other bodily fluids. They should be disposed of per your facility's procedures for biohazardous waste.
Product codes
GEX
Device Description
The SLT select fiber delivery system and contact tips is the transmission path for 810mm, 980mm wavelength laser generator to the surgical site, with the optical fiber as the propagation medium, by transmitting the diseased area, to achieve the treatment of the disease.
The SLT select fiber delivery system and contact tips, except for the CFE series of needle-tip one-piece flexible fibers, are fitted with a metal connector at the metal connector is threaded to connect to the contact laser tread, The FEF series models can be used as non-contact lasers without a treatment head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The bench testing of SLT Select Fiber Delivery Systems and Contact Tips and non-clinical testing is performed on new devices is to demonstrate the substantial equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the testing demonstrate the standards and matching the performance of new devices to the predicate devices. The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility test
ln vitro cytoxicity test, Skin sensitization, Intracutaneous reactivity, Pyrogen, Acute systemic toxicity were conducted according to ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-11:2017.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
December 22, 2024
Image /page/0/Picture/1 description: The image contains 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.
JiangXi Medex Technology Co.,Ltd % Owen He Consultant Microkn Medical Technology Service (Shanghai) Co., Ltd. Room 901,No.889, Pinglu Road, Jing'an District Shanghai. China
Re: K243121
Trade/Device Name: SLT Select Fiber Delivery System and Contact Tips (models SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTR1.5; MTR3.5; MTRG1.5; MTRG2.5; MTRG3.5; MT1.5; MT3.5; DF2; MTRGL3.5; MTRL6; MTRL7; MTRL8; MTRL10; R3ERP2; R4ERP2; D1ERP4; D3ERP4; D3GRP4; D3GRP10; D3GRP14; D3MTRG4; D3MTRG20; SERP4; SGRP4; SMD3.5; SMTRG3.5).
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 20, 2024 Received: September 30, 2024
Dear Owen He:
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
1
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" (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 QS 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 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 (OS) 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-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
2
3
803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
YAN FU -S
Digitally signed by YAN FU -S
Date: 2024.12.22 01:42:52 -05'00"
for Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K243121
Device Name
SLT Select Fiber Delivery System and Contact Tips (models SSRH 8-SMA: FEF 2.2-SMA: CFE 0.6-SMA: SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2;
Indications for Use (Describe)
The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the precise tissue effects of incision, excision, vaporization of tissue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905connector.
·Laser must operate at a wavelength between 532 and 1064 nm.
- Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.
- · Laser must have a numerical aperture of 0.35 or less.
· Laser must accept universal SMA-905 connector, SLT proprietary connector, or an appropriate adapter into its fiber launch connector.
Note: These Fiber Delivery Systems are cleared for the particular indications of the laser system to which they are connected.
During use these products are exposed to biohazardous substances such as blood and other bodily fluids. They should be disposed of per your facility's procedures for biohazardous waste.
| 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."
4
510(k) Summary Prepared on: 2024-11-28 510(k) #: K243121 Contact Details 21 CFR 807.92(a)(1) JiangXi Medex Technology Co.,Ltd Applicant Name ChengXin Avenue, Xinfeng Industrial Area Xinfeng, Jiangxi CN 330104 Applicant Address Jiangxi 330104 China Applicant Contact Telephone +86 13530954829 Applicant Contact Ms. Zhang Kaixia Applicant Contact Email m055@jiangximedex.com Microkn Medical Technology Service (Shanghai) Co., Ltd. Correspondent Name Room 901,No.889, Pinglu Road, Jing'an District, Shanghai Shanghai Correspondent Address China +86 13795451145 Correspondent Contact Telephone Mr. Owen He Correspondent Contact Correspondent Contact Email fda@microkn.com 21 CFR 807.92(a)(2) Device Name SLT Select Fiber Delivery System and Contact Tips (Models: SSRH 8-SMA: TCRH 7-SMA: FEF 2.2-SMA: CFE 0.6-SMA: SSRH 8Z-SMA: SSRH 4-SMA: SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; Device Trade Name GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTR1.5; MTR3.5; MTRG1.5; MTRG2.5; MTRG3.5; MT1.5; MT3.5; DF2; MTRGL3.5; MTRL6; MTRL7; MTRL8; MTRL10; R3ERP2; R4ERP2; D1ERP4; D3ERP4; D3GRP4; D3GRP10; D3GRP14; D3MTRG4; D3MTRG20; SERP4; SGRP4; SMD3.5; SMTRG3.5) Laser surgical instrument for use in general and plastic surgery and in Common Name dermatology Classification Name Powered Laser Surgical Instrument Regulation Number 878.4810 GEX Product Code(s) Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
Predicate #
Predicate Trade Name (Primary Predicate is listed first)
Product Code
5
SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
GEX
21 CFR 807.92(a)(4)
Device Description Summary
The SLT select fiber delivery system and contact tips is the transmission path for 810mm, 980mm wavelength laser generator to the surgical site, with the optical fiber as the propagation medium, by transmitting the diseased area, to achieve the treatment of the disease.
The SLT select fiber delivery system and contact tips, except for the CFE series of needle-tip one-piece flexible fibers, are fitted with a metal connector at the metal connector is threaded to connect to the contact laser tread, The FEF series models can be used as non-contact lasers without a treatment head.
Intended Use/Indications for Use
The SLT Select Fiber Delivery Systems and Contact Tips are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems and tips achieve the tsue effects of incision, vaporizationand coagulation of tisue. The universal SMA-905 connector allows this family of fiber delivery systems to be used with any laser system of 532 to 1064 nm wavelength which accepts the SMA-905connector.
·Laser must operate at a wavelength between 532 and 1064 nm.
-
- Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.
·Laser must have a numerical aperture of 0.35 or less.
- Laser must operate in Continuous Wave (CW) or Quasi Continuous Wave (Quasi CW) mode.
-
Laser must accept universal SMA-905 connector, or an appropriate adapter into its fiber launch connector. Note: These Fiber Delivery Systems are cleared for use for the laser system to which they are connected. During use these products are exposed to biohazardous such as blood and other bodily fluids. They should be disposed of per your facility's procedures for biohazardous waste.
Indications for Use Comparison
The indication for use is the same with predicate devices.
Technological Comparison
The purposed device and the predicated device are same in product code, requlations for use, Patient Population, Transmission efficiency, The tensile strength of the ioint between the optical fiber transmission body and the connector, The optical fiber tensile strength, minimum bending radius, optical fiber bending fatique resistance, Divergence angle,
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Non-clinical Testing
The bench testing of SLT Select Fiber Delivery Systems and Contact Tips and non-clinical testing is performed on new devices is to demonstrate the substantial equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the testing demonstrate the standards and matching the performance of new devices to the predicate devices. The following performance data were provided in support of the substantial equivalence determination.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
6
Biocompatibility test
ln vitro cytoxicity test, Skin sensitization, Intracutaneous reactivity, Pyrogen, Acute systemic toxicity were conducted according to ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-11:2017.
No clinical study is included in this submission.
The SL T Select Fiber Delivery Systems and Contact Tips are substantially equivalent to the predicate device.