(202 days)
Use in laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.
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.
The FastClamp Endoscopic Clamping System underwent several non-clinical tests to demonstrate its performance and safety, as described below:
1. Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance and Study |
|---|---|
| FastClamp Jaw Capability Testing | |
| - 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. | The pass results in TN100346 (Exhibit 6) show that 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. |
| FastClamp Bed Frame Fixation Testing | |
| - 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. | The pass results in TN100346 (Exhibit 6) show that 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 | |
| - The FastClamp Endoscopic Clamping System is capable of holding the liver retractor and supporting simulated liver weight of 4kg. | The pass results in TN100384 show that 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 | |
| - 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. | The pass results in TN100372 (Exhibit 7) show that 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. |
| FastClamp Juustification of 2 Year Usable Lifespan | |
| - The FastClamp Endoscopic Clamping System is capable of passing 200 full clean, wash and autoclave cycles, and still functions safely and correctly. | The pass results in TN100362 (Exhibit 10) show that 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. |
| FastClamp Steam Sterilization Validation | The steam sterilization process used for FastClamp Endoscopic Clamping System has been validated in accordance with ISO 17665 (Sterilization of health care products – Moist heat). The results showed that 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. (Full report in TN100420) |
| Materials Biocompatibility (Cytotoxicity) | The extract of the negative control (polypropylene filters) was non-cytotoxic to L929 cells. The extract of the positive control (rubber bands) was cytotoxic to L929 cells. The extract of the test material was non-cytotoxic. (Full report in TN 100359, Exhibit 9) |
| Materials Biocompatibility (Extractivity Testing) | The gravimetric and visual results show that no significant levels of extractable material were found. This justified not conducting ISO 10993-10 skin irritation and skin sensitization tests, as only the extractant would be assessed if no measurable extractable material was present. (Full report in TN 100359, Exhibit 9) |
2. Sample Sized Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes as individual quantities for each test within the "test set" framework typical for AI/software validation. Instead, it describes multiple bench tests, stress tests, and validation procedures.
- FastClamp Jaw capability testing, Bed frame fixation testing, Recommended loadings: The sample size for these tests is not explicitly quantified as a "test set" but rather described as testing the FastClamp Endoscopic Clamping system, implying testing on representative units.
- Packaging drop testing: The inspection was 100% of the product after dropping, implying that the tested units were fully inspected.
- 2 year usable lifespan: The test involved "200 full clean, wash and autoclave cycles" on the FastClamp Endoscopic Clamping system, indicating repeated cycling on one or more representative units.
- Materials Biocompatibility: These tests (Cytotoxicity and Extractivity) were performed on "the test material," implying samples of the materials used in the device.
The data provenance is not explicitly stated in terms of country of origin but is from internal non-clinical testing ("Bench Testing"). The tests are prospective in nature, as they are specifically designed to evaluate the physical and material properties of newly manufactured devices under controlled conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This section is not applicable as the validation criteria are based on objective physical measurements and standardized test procedures (e.g., ability to hold weight, withstand cycles, ISO standards, ASTM standards), not subjective expert interpretation of output or images. Therefore, "ground truth" as it relates to expert consensus is not relevant here.
4. Adjudication Method for the Test Set:
Not applicable. The tests involve objective measurements against predefined input criteria, not interpretation or adjudication by multiple individuals.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a mechanical clamping system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical clamping system, not an algorithm. The "standalone" performance here refers to the device's physical capabilities without human intervention (e.g., holding a load), which is precisely what the bench tests evaluate.
7. The Type of Ground Truth Used:
The "ground truth" used is based on:
- Objective Physical Measurements: Forces (1kg, 10kg, 4kg), dimensions (Ø4.2-Ø7.4, Ø9.2-Ø11.4), height (610mm drop).
- Standardized Test Protocols: ASTM D4169-1996 for packaging, ISO 17665 for sterilization, ISO 10993-1:2002 for biocompatibility.
- Functional Criteria: Ability to remain static, ability to deploy locking mechanism, absence of visible defects, safe and correct function after cycles, satisfaction of sterilization requirements, non-cytotoxicity, and no significant extractable material.
8. The Sample Size for the Training Set:
Not applicable. This device is a mechanical product and does not involve machine learning or a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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SECTION 5:
510(k) SUMMARY
| Submitter: | Surgical Innovations plc.Clayton Wood House6 Clayton Wood BankLeedsLS16 6QZUnited KingdomTel.: +44 113 230-7597Fax: +44 113 230-7598 | SEP | 7 2010 |
|---|---|---|---|
| Contact Person: | Mike WhiteProduct Development Director | ||
| Date SummaryPrepared: | 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
:
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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:
1
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.
{2}------------------------------------------------
Nonclinical tests summary
1. Bench Testing
FastClamp Jaw capability testing
For this test the input criteria was determined to be:
- 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.
The pass results in TN100346 (Exhibit 6) show that 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
For this test the input criteria was determined to be:
- 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.
The pass results in TN100346 (Exhibit 6) show that 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
For this test the input criteria was determined to be:
- The FastClamp Endoscopic Clamping System is capable of holding the liver retractor and . supporting simulated liver weight of 4kg.
The pass results in TN100384 show that 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.
{3}------------------------------------------------
Packaging drop testing
For this test the input criteria was determined to be:
- 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.
The pass results in TN100372 (Exhibit 7) show that 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
For this test the input criteria was determined to be:
- The FastClamp Endoscopic Clamping System is capable of passing 200 full clean, wash and . autoclave cycles, and still functions safely and correctly.
The pass results in TN100362 (Exhibit 10) show that 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
The steam sterilization process used for FastClamp Endoscopic Clamping System has been validated in accordance with ISO 17665 Sterilization of health care products – Moist heat. The results showed that 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.
The full report of this testing is provided in TN100420.
{4}------------------------------------------------
4. Materials Biocompatibility
From ISO 10993-1:2002, FastClamp Endoscopic Clamping System is an external communicating device with duration < 24 hours, therefore initial tests for consideration are:
-
- Cytotoxicity
.
- Cytotoxicity
-
- Sensitization
-
- Intracutaneous reactivity.
In order to minimize animal tests, an extractivity test was conducted to determine the necessity for sensitization and intracutaneous reactivity.
1. Cytotoxicity Test
The result has showed that the extract of the negative control (polypropylene filters) was noncytotoxic to L929 cells under the conditions of this test.
The extract of the positive control (rubber bands) was cytotoxic to L929 cells under the conditions of this test.
The extract of the test material was non-cytotoxic.
The full report of this testing (ref. TN 100359) is provided in Exhibit 9.
2. Extractivity Testing
...
The gravimetric and visual results show that no significant levels of extractable material were found. As such it is considered that the ISO 10993-10 skin irritation and skin sensitization tests should not be conducted. The justification for this is that if no measureable levels of extractable material are produced then it would only be the extractant that is being assessed.
The full report of this testing (ref. TN 100359) is provided in Exhibit 9
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgical Innovations plc. % Mr. Mike White Product Development Director Clayton Wood House 6 Clayton Wood Bank Leeds, LS16 6QZ United Kingdom
7 2010 SEP
Re: K100442
Trade/Device Name: FastClamp Endoscopic Clamping System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: July 12, 2010 Received: July 14, 2010
Dear Mr. White:
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 (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.
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Page 2 - Mr. Mike White
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/7/Picture/0 description: The image shows the text 'K100442 page 1 of 1' in a handwritten style. The text appears to be a page number or document identifier. The handwriting is clear and legible, with the numbers and letters easily distinguishable.
SECTION 4:
SEP 7 2010
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Not known
Device Name:
FastClamp Endoscopic Clamping System
Indications for Use:
Use in laparoscopic procedures for the surgeon to clamp endoscopic instruments in a fixed position for a period of time.
Prescription Use X
(Per 21 CFR 801 Subpart D)
AND/ OR
Over-The-Counter Use _
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100442
10
§ 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.