(60 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML devices.
No
The device is used to clear the surgical site for better visualization during procedures, not to treat a disease or condition.
No
The device aids visualization during surgical procedures by providing suction and irrigation, but it does not perform any diagnostic function such as identifying diseases or conditions. Its purpose is to facilitate the surgery itself.
No
The device description explicitly details physical components like a shaft, buttons, tubes, and hand pieces, indicating it is a hardware device, not software-only.
Based on the provided information, the LAP-iX Suction Irrigation device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide suction and irrigation during surgical procedures to aid visualization by removing fluids. This is a direct intervention on the patient's body during surgery.
- Device Description: The description details a physical device used for fluid management within the surgical field.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) outside of the body to diagnose a condition, monitor a treatment, or screen for diseases. IVDs are specifically designed for these types of in vitro analyses.
The LAP-iX Suction Irrigation is a surgical instrument used for fluid management during procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The LAP-iX Suction Irrigation provides suction to a surgical site during laparoscopic and endoscopic procedures.
Product codes
HET
Device Description
The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. It consists of 4.50 diameter shaft, suction/irrigation buttons and suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation). All equipment conforming to this specs can be used.
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
Prescription Use
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 following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- Sterilization Validation Test in accordance with ISO11737-1
- Shelf Life Validation Test
- Biocompatibility Tests in accordance with ISO 10993 (Cytotoxicity, Ethylene Oxide Sterilization residuals, Skin Sensitization, Systemic Toxicity, Irritation)
- Performance Tests: Appearance, Measurement, Leakage, Tensile strength, Ethylene Oxide Sterilization Residuals, Sterility Test
Key Metrics
Not Found
Predicate Device(s)
Surgiwand II (K903207) by COVIDIEN
Reference Device(s)
Aqua-Purator (K982518), Cassette Pump (K042454)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.
0
November 28, 2017
Sejong Medical Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620
Re: K173111
Trade/Device Name: LAP-iX Suction Irrigation Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope and Accessories Regulatory Class: Class II Product Code: HET Dated: September 26, 2017 Received: September 29, 2017
Dear Priscilla Chung:
We have reviewed vour 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. 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 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173111
Device Name
LAP-iX Suction Irrigation
Indications for Use (Describe)
The LAP-iX Suction Irrigation provides suction to a surgical site during laparoscopic and endoscopic procedures.
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
510(k) Summary (K17311)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:
1. Submitter/Applicant
Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, Gyeonggi-do Republic of Korea 10880
Tel: +82-31-945-8191 Fax: +82-31-945-8190
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- . Trade Name: LAP-iX Suction Irrigation
- Common Name: Gynecologic laparoscope and accessories ●
- Classification: Class II ●
- Classification regulation: 21 CFR 884.1720
- Product Code: HET
4. Predicate Devices:
Surgiwand II (K903207) by COVIDIEN
5. Description:
The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. It consists of 4.50 diameter shaft, suction/irrigation buttons and
4
suction/irrigation tubes with hand piece. It has two types of hand piece, pistol and trumpet grip. The subject device is compatible with all suction and irrigation pumps in the market which have the connecting tubes or connectors of Ø10mm (Suction) or Ø7mm(Irrigation). All equipment conforming to this specs can be used. The following devices are the example of the compatible device.
| Suction/Irrigation Pump | |
|---|---|
| Device Name | Aqua-Purator |
| Applicant Name | WISAP |
| 510(K) Number | K982518 |
| Device Name | Cassette Pump |
|---|---|
| Applicant Name | Stryker |
| 510(K) Number | K042454 |
6. Indication for use:
The LAP-iX Suction Irrigation provides suction or irrigation to a surgical site during laparoscopic and endoscopic procedures.
7. Performance Data
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- · Sterilization Validation Test in accordance with ISO11737-1
- · Shelf Life Validation Test
- · Biocompatibility Tests in accordance with ISO 10993
| Cytotoxicity | ISO 10993-5 |
|---|---|
| Ethylene Oxide Sterilization | |
| Residuals | ISO 10993-7 |
| Skin Sensitization | ISO 10993-10 |
| Systemic Toxicity | ISO 10993-11 |
| Irritation | ISO 10993-10 |
- · Performance Tests: Appearance, Measurement, Leakage, Tensile strength, Ethylene Oxide Sterilization Residuals, Sterility Test
8. Basis for Substantial Equivalence
The subject device device, LAP-iX Suction Irrigation, is substantially equivalent to the predicate device, Surgiwand II (K903207). Both the devices have the same Indications for Use statement except the fact the subject device does not include
5
cautery procedure. However, this difference does not raise a question since the subject device does not introduce a new intended use. The both devices provide suction and irrigation functions during laparoscopic procedures. The raw material for the tube is the same between the devices which is stainless steel. The difference is that the subject device offers an additional handle type which is the pistol handle. However, this difference does not raise a question since the handle type is just for the user's preference and does not affect safety and performance. Another difference is dimension that the tube diameter of the subject device is slightly smaller than the predicate device and its length is slightly longer than the predicate device. However, the difference is very small that it would not raise a question in safety and effectiveness according to the performance test results including the tensile strength test. Based on the information submitted herein, we determined that the subject device is substantially equivalent to the predicate device.
9. Conclusion
Upon reviewing the information including testing data provided in this submission and comparing intended use, principle of operation and overall technological characteristics, we conclude that the LAP-iX Suction Irrigation is substantially equivalent to the predicate devices.