K Number

Device Name

FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM

Manufacturer

SURGICAL INNOVATIONS GROUP PLC

Date Cleared

2010-09-07

(202 days)

Product Code

GCJ

Regulation Number

876.1500

Intended Use

Use in laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.

Device Description

The FastClamp Endoscopic Clamping System is a non sterile, reusable, laparoscopic clamp instrument. It comprises a table clamp to securely attach to the operating table accessory rail, and an instrument clamp to lock the instrument in place once the instrument has been positioned.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K092684, K070509

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical clamping and stability, with no mention of AI/ML terms or functions.

Therapeutic

No
The device is a laparoscopic clamp that holds static instruments during surgery. It does not treat or cure a disease or condition, which is a characteristic of a therapeutic device.

Diagnostic

The device is described as a clamping system used to hold endoscopic instruments in a fixed position during laparoscopic procedures. Its function is mechanical support, not to diagnose or detect medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "non sterile, reusable, laparoscopic clamp instrument" and describes physical components like a "table clamp" and "instrument clamp," indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "clamp endoscopic instruments in a fixed position for a period of time" during laparoscopic procedures. This is a mechanical function performed on instruments used in a surgical procedure, not a test performed on a biological sample to provide diagnostic information.
Device Description: The description details a mechanical clamping system that attaches to an operating table and holds instruments. This aligns with a surgical accessory, not a diagnostic device.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's condition.
Performance Studies: The performance studies focus on the mechanical strength, stability, and durability of the clamping system, which are relevant to a surgical instrument accessory. They do not involve any diagnostic performance metrics.

IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FastClamp Endoscopic Clamping System is indicated for use in laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.

Product codes (comma separated list FDA assigned to the subject device)

GCJ

Device Description

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

1. Bench Testing
FastClamp Jaw capability testing:

Input criteria: 5mm (between Ø4.2- Ø7.4) and 10mm (Ø9.2- Ø11.4) nominal test bars remain static between the jaws when a load of 1kg is applied. 5mm and 10mm nominal test bars (between Ø4.2- Ø7.4 and Ø9.2- Ø11.4) are positioned in appropriate recess in the jaws and the locking mechanism can be deployed.
Key results: The FastClamp Endoscopic Clamping system passes the input criteria, capable of accommodating a range of instruments between Ø4.2- Ø7.4 and Ø9.2- Ø11.4 , and gripping them to withstand a load of 1kg.

Fast Clamp bed frame fixation testing:

Input criteria: FastClamp Endoscopic clamping system is attached to the bed rail over drape; it does not move when a load of 10kg is applied to front, back and both sides.
Key results: The FastClamp Endoscopic Clamping system passes the input criteria to withstand a load of 10kg applied to front, back and both sides. It provides an extremely strong and stable instrument platform once it has been correctly adjusted and locked into position.

Recommended loadings for FastClamp Endoscopic Clamping System:

Input criteria: The FastClamp Endoscopic Clamping System is capable of holding the liver retractor and supporting simulated liver weight of 4kg.
Key results: FastClamp Endoscopic Clamping system passes the input criteria: capable of holding a liver retractor in a static position during retraction of simulated liver weights up to 4kg which is double the weight of the average male adult liver.

Packaging drop testing:

Input criteria: Pass in accordance with pass criteria ASTM D4169-1996. After 100% inspection of product after dropping from a height of 610mm, there should be no visible defects found in the product.
Key results: The FastClamp Endoscopic Clamping System passes the input criteria where the packaging remained in one piece and the product was not damaged in any way.

2. FastClamp Justification of 2 year useable lifespan

Input criteria: The FastClamp Endoscopic Clamping System is capable of passing 200 full clean, wash and autoclave cycles, and still functions safely and correctly.
Key results: FastClamp Endoscopic Clamping system passes the input criteria, capable of functioning safely after 200 full clean, wash and autoclave cycles. The cosmetic change in color is due to the temperature during autoclaving, and once the change has occurred, there is no evidence of deterioration in the properties of function of the plating.

3. FastClamp steam sterilization validation

Study type: Steam sterilization validation in accordance with ISO 17665 Sterilization of health care products – Moist heat.
Key results: The sterilization requirement has been satisfied in accordance with ISO17665. FastClamp Endoscopic Clamping System Instruction for Use (IFU) has been updated to reflect the sterilization parameters which are 135°C for 30 minutes using gravity displacement with 90 minutes minimum dry time.

4. Materials Biocompatibility

Tests for consideration (from ISO 10993-1:2002 for external communicating device with duration

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Summary

SECTION 5:

510(k) SUMMARY

| Submitter: | Surgical Innovations plc.
Clayton Wood House
6 Clayton Wood Bank
Leeds
LS16 6QZ
United Kingdom

Tel.: +44 113 230-7597
Fax: +44 113 230-7598 | SEP | 7 2010 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------|
| Contact Person: | Mike White
Product Development Director | | |
| Date Summary
Prepared: | 10 February 2010 | | |
| Trade Name: | FastClamp Endoscopic Clamping System | | |
| Common Name: | Endoscope and accessories | | |
| Classification Name: | Laparoscope, General and Plastic Surgery
(21 CFR 876.1500, Product Code GCJ) | | |
| Equivalent to: | Laparoscopic Retractors- Cardinal Health, Inc. (K092684)
FISSO Holding System - Baitella AG (K070509).
Mediflex Flex Arm Systems - Mediflex surgical products (pre-amendments device).
Thompson Retractor - Thompson Surgical Instruments, Inc. (pre-amendments device) | | |

月100442

The FastClamp Endoscopic Clamping System is a non sterile, reusable, Device Description: laparoscopic clamp instrument. It comprises a table clamp to securely attach to the operating table accessory rail, and an instrument clamp to lock the instrument in place once the instrument has been positioned.

The FastClamp Endoscopic Clamping System is indicated for use in Intended Use: laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.

Substantial Equivalence:

Determination of substantial equivalence for the FastClamp Endoscopic Clamping System was based on comparison to the predicate devices in terms of intended use and device technological characteristics, such as design features, materials of composition, principle of operation and presentation. The FastClamp Endoscopic Clamping System is substantially equivalent to the Laparoscopic Retractors in terms of their intended use. The FastClamp Endoscopic Clamping System is substantially equivalent to the FISSO Holding System, MediFlex Flex Arm Systems, and Thompson Retractor in terms of the intended use, design features, material, sterilization, principle of operation and presentation.