LIGA-LOOP SUTURE APPLICATOR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the number '993695'. The characters are written in a bold, handwritten style, with some variations in stroke thickness. # LIGA-LOOP™ Suture Applicator # SUMMARY OF SAFETY AND EFFECTIVENESS This 510(k) summary of safety and cffectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 80.192. - Submitter's name, address, telephone number, contact person, and date 1. summary prepared: - Submitter: ಡಿ HysteRx™, Inc. 32236-E Paseo Adelanto San Juan Capistrano, CA 92675 (949) 488-8701 - b. Contact Person: Judy F. Gordon, D.V.M. Official Correspondent for HysteRx™, Inc. ClinReg Consulting Services, Inc. 18732 Saginaw Irvine, CA 92612 (949) 854-6314 (phone) (949) 854-9652 (fax) - c. Date Summary Prepared: March 29, 2000 - 2. Name of device, including trade name and classification name: - Trade/Proprietary Name: a. LIGA-LOOP™ Suture Applicator - b. Classification Name: Instrument, Ligature Passing & Knot Tying #### Identificution of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed: | a. | Company: | Advanced Surgical, Inc. | | |----|---------------|----------------------------|--| | | Device: | Endoscopic Ligation Device | | | | 510(k): | K950126 | | | | Date Cleared: | April 13, 1995 | | - b. Company: Olympus Corporation Device: Resectoscope Sheath 510(k): K931994/A LIGA-LOOP Sulure Applicator K993695 Summary of Safety and Effectiveness March 30, 2000 1 of 4 {1}------------------------------------------------ Date Cleared: February 17, 1994 #### 4. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties): The LIGA-LOOP™ Suture Applicator is an instrument designed for ligation of soft tissue and blood vessels during surgical procedures. The device also incorporates a central lumen for use in irrigation and/or imaging to increase patient safety during suturing. The LIGA-LOOP™ Suture Applicator contains similar materials, is of similar design, and has the same operating principle as the predicate devices. #### છે. Statement of intended use: The T.IGA-LOOP™ Suture Applicator is indicated for use in the ligation of soft tissue and blood vessels during open and guidance-assisted surgical procedures. The LIGA-LOOP Suture applicator with polyglycolic acid (PGA) suture and the LIGA-LOOP Suture Applicator with gut suture (plain and chromic) are intended for the same use, excluding cardiovascular and neurological procedures. #### 6. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device. A comparison of the technological characteristics of the device and its predicate is shown in the following table: > LIGA-L()OP Suture Applicator K993695 Summary of Safety and Effectiveness March 30, 2000 2 of 4 {2}------------------------------------------------ Page 4/5 | CHARACTERISTICS | LIGA-LOOPT™ Suture<br>Applicator<br>HysteRx™, Inc. | Endoscopic Ligation<br>Device<br>Advanced Surgical | Resectoscope Sheath<br>Olympus Corporation | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Intended Use | For ligation of soft tissue<br>and blood vessels during<br>open and guidance-<br>assisted surgical<br>procedures<br>For LIGA-LOOP with<br>PGA or gut suture,<br>cardiovascular and<br>neurological procedures<br>are excluded | For tying sutures around<br>structures such as blood<br>vessels and ducts during<br>minimally invasive<br>(laparoscopic) surgery | For insufflation, irrigation<br>and aspiration | | Operating Principle | Passes suture around<br>targeted tissue and/or<br>vessel using snare device<br>to complete ligation<br>No suture needles used.<br>Central lumen provides<br>for fluid management<br>and/or imaging during<br>suturing | Passes suture around<br>targeted tissue and/or<br>vessel using snare device<br>to complete ligation<br>No suture needles used. | Allows for fluid<br>management during<br>hysteroresection<br>procedures | | Performance Testing | Knot pull strength testing<br>and diameter<br>measurements of suture<br>materials | Knot pull strength testing,<br>diameter measurements of<br>suture materials, ligation<br>leakage testing | N/A | | Handpiece and Tip<br>Configuration: | Slide-type handpiece, J-<br>shaped tip for grasping<br>tissue and/or vessel | Stapler-type handpiece,<br>with J-shaped tip for<br>grasping tissue and/or<br>vessel | N/A | | Dimensions:<br>Cannula (Fr): | Outer shaft is available in<br>2 sizes: 30 Fr and<br>39 Fr | Made to fit within 7, 10,<br>11, and 12 mm trocar<br>cannulas | Outer diameter is<br>18.9 Fr to 28 Fr | | Cannula Shaft Length<br>(cm): | Available in 2 sizes, 12<br>cm and 24 cm | Unknown | N/A | | Lumen Diameter<br>(mm): | Irrigation/ Aspiration/<br>Imaging lumen is<br>available in 2 sizes, 4.8<br>mm and 9 mm in diameter | N/A | Lumen diameter is 4-6<br>mm | | Patient contact portion<br>of device* | Outer Shaft, Jaws, Snare,<br>and Suture | Outer Shaft, Functional<br>Tip, Snare, and Suture | Sheath | | Materials: | | | | | Handle | ABS | Stainless steel or<br>aluminum | N/A | | Outer shaft | Stainless steel | Stainless steel or<br>aluminum | Stainless steel | | Tips | Stainless steel, nitinol | Polycarbonate, stainless<br>steel | Zirconium oxide ceramic | | Suture Cartridge | N/A | Polycarbonate, stainless<br>steel | N/A | | Sutures | Plain gut, chromic gut,<br>silk, PGA | Chromic Gut, silk,<br>polypropylene | N/A | | Potting | Epoxy | N/A | N/A | | Central Lumen | Stainless steel | N/A | Stainless steel | | Sterilization method | Gamma radiation, 25-40<br>kgy | Chromic gut and silk<br>cartridges: gamma<br>radiation:<br>polypropylene:EO<br>Handle: autoclave. | Unknown | | Disposable/Reusable | Single use, disposable | Suture cartridges: single<br>use, disposable<br>Handle: reusable,<br>autoclavable | Reusable | ### Comparative Technological Characteristics 17-11- . CLINERO LIGA-LOOP Suture Applicator K993692 Summary of Safety and Effectiveness March 30, 2000 {3}------------------------------------------------ #### Brief summary of nonclinical tests and results: 7. む」にはない The LIGA-I.OOP™ Suture Applicator was tested to ensure that manipulation during installment of the suture to the applicator does not significantly affect suture diameter or knot pull-strength of the suture material. Test results indicate rcliable performance when the device is used in accordance with the Instructions for Use. Manipulation of the suture material does not affect suture diameter or knot pull-strength. The LIGA-LOOP™ Suture Applicator does not raise any new safety, effectiveness, or performance issues. > LIGA-LOOP Suture Applicator K993692 Summary of Safety and Effectiveness March 30, 2000 4 of 4 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal, there is an emblem that appears to be three stylized birds in flight. ## APR 1 3 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 HysteRx™ c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 18732 Saginaw Irvine, California 92612 Re: K993695 Trade Name: LIGA-LOOPTM Suture Applicator Regulatory Class: II Product Code: GAL, GAM, GAP, GEA Dated: February 15, 2000 Received: February 17, 2000 Dear Dr. Gordon: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {5}------------------------------------------------ Page 2 - Judy F. Gordon, D.V.M. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Dina R Lochner. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # K993695 Page __ l__ of__l_ 510(k) Number (if known): Device Name: LIGA-LOOP Suture Applicator Indications for Use: The LIGA-LOOP Suture Applicator is intended for use in the suturing of soft tissue and ligation of blood vessels during open and guidance-assisted surgical procedures. The LIGA-LOOP Suture Applicator with polyglycolic acid (PGA) suture and the LIGA-LOOP Suture Applicator with gut suture (plain and chromic) are intended for the same use, excluding cardiovascular and neurological procedures. ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) #### Concurrence of CDRH, Office of Device Evaluation (ODE) Duna R. Vochner. Sign-Off ion of General Restorative Devices Number K993695 Image /page/6/Picture/10 description: The image shows the words "Perscription Use" in a simple, sans-serif font. To the right of the words, there is a large "X" mark. The "X" mark appears to be hand-drawn, with slightly uneven lines. OR ()ver-lihe-Counter Use (Optional Format 1-2-96)