(163 days)
Not Found
No
The summary describes a mechanical surgical instrument for suturing and ligation, with no mention of AI, ML, image processing, or data-driven decision making.
No
The device is a suture applicator used for mechanical tasks (suturing and ligation) during surgery, not for preventing, diagnosing, treating, or curing a disease or condition.
No
The device is described as a "Suture Applicator" intended for "suturing of soft tissue and ligation of blood vessels" during surgical procedures. Its function is to apply sutures, not to diagnose conditions or diseases.
No
The device description clearly indicates it is a physical instrument ("instrument designed for ligation of soft tissue and blood vessels") and mentions materials and design, which are characteristics of hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The LIGA-LOOP Suture Applicator is a surgical instrument used during surgical procedures to physically manipulate and ligate soft tissue and blood vessels. It is a tool used on the patient's body, not a test performed on a sample from the patient's body.
- Intended Use: The intended use clearly states its purpose is for "suturing of soft tissue and ligation of blood vessels during open and guidance-assisted surgical procedures." This is a surgical function, not a diagnostic one.
The information provided describes a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LIGA-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.
Product codes (comma separated list FDA assigned to the subject device)
GAL, GAM, GAP, GEA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue and blood vessels
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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
-
- 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
Applicator
HysteRx™, Inc. | Endoscopic Ligation
Device
Advanced Surgical | Resectoscope Sheath
Olympus Corporation |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | For ligation of soft tissue
and blood vessels during
open and guidance-
assisted surgical
procedures
For LIGA-LOOP with
PGA or gut suture,
cardiovascular and
neurological procedures
are excluded | For tying sutures around
structures such as blood
vessels and ducts during
minimally invasive
(laparoscopic) surgery | For insufflation, irrigation
and aspiration |
| Operating Principle | Passes suture around
targeted tissue and/or
vessel using snare device
to complete ligation
No suture needles used.
Central lumen provides
for fluid management
and/or imaging during
suturing | Passes suture around
targeted tissue and/or
vessel using snare device
to complete ligation
No suture needles used. | Allows for fluid
management during
hysteroresection
procedures |
| Performance Testing | Knot pull strength testing
and diameter
measurements of suture
materials | Knot pull strength testing,
diameter measurements of
suture materials, ligation
leakage testing | N/A |
| Handpiece and Tip
Configuration: | Slide-type handpiece, J-
shaped tip for grasping
tissue and/or vessel | Stapler-type handpiece,
with J-shaped tip for
grasping tissue and/or
vessel | N/A |
| Dimensions:
Cannula (Fr): | Outer shaft is available in
2 sizes: 30 Fr and
39 Fr | Made to fit within 7, 10,
11, and 12 mm trocar
cannulas | Outer diameter is
18.9 Fr to 28 Fr |
| Cannula Shaft Length
(cm): | Available in 2 sizes, 12
cm and 24 cm | Unknown | N/A |
| Lumen Diameter
(mm): | Irrigation/ Aspiration/
Imaging lumen is
available in 2 sizes, 4.8
mm and 9 mm in diameter | N/A | Lumen diameter is 4-6
mm |
| Patient contact portion
of device* | Outer Shaft, Jaws, Snare,
and Suture | Outer Shaft, Functional
Tip, Snare, and Suture | Sheath |
| Materials: | | | |
| Handle | ABS | Stainless steel or
aluminum | N/A |
| Outer shaft | Stainless steel | Stainless steel or
aluminum | Stainless steel |
| Tips | Stainless steel, nitinol | Polycarbonate, stainless
steel | Zirconium oxide ceramic |
| Suture Cartridge | N/A | Polycarbonate, stainless
steel | N/A |
| Sutures | Plain gut, chromic gut,
silk, PGA | Chromic Gut, silk,
polypropylene | N/A |
| Potting | Epoxy | N/A | N/A |
| Central Lumen | Stainless steel | N/A | Stainless steel |
| Sterilization method | Gamma radiation, 25-40
kgy | Chromic gut and silk
cartridges: gamma
radiation:
polypropylene:EO
Handle: autoclave. | Unknown |
| Disposable/Reusable | Single use, disposable | Suture cartridges: single
use, disposable
Handle: reusable,
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)