(182 days)
Use in laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to manipulate tubing and to generally assist with the placement of a gastric band.
The LogiFlex Laparoscopic Band Positioning Device is a sterile, single-use, laparoscopic, blunt dissection instrument. It comprises a shaft with a distal articulating tip incorporating a slot that forms a hook for capturing suture threads and tubing. The LogiFlex Laparoscopic Band Positioning Device is designed to be connected to and used with the reusable, ratchet handle of the Logic Monopolar Laparoscopic Scissors in order to effect articulation of the distal tip. The LogiFlex Laparoscopic Band Positioning Device is not designed to be used with an electrocautery connection.
The provided text describes nonclinical bench testing for the LogiFlex Laparoscopic Band Positioning Device. There is no information about clinical studies with human participants, thus questions related to expert ratings, MRMC studies, or multi-reader performance cannot be answered.
Here's the information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Distal Tip Pull Testing | A tensile axial load > 2kg when pulling suture. | Achieved a load of 2.96kg (pre-production), 2.6kg (production standard) |
| Product straightens to -5° to 0° for cannula introduction/removal. | Passed (articulating from 0° to 90°) | |
| Product articulates to ≥ 90° to allow positioning around the esophagus. | Passed (articulating from 0° to 90°) | |
| Sideway Force Testing | A sideway force ≥ 0.54kg when pulling suture. | Achieved a sideway force of 0.54kg |
| Product straightens to -5° to 0° for cannula introduction/removal. | Passed (articulating from 0° to 90°) | |
| Product articulates to ≥ 90° to allow positioning around the esophagus. | Passed (articulating from 0° to 90°) | |
| Crimped Nipple Pull Out Testing | Crimped nipple to withstand 5kg amount of force. | Achieved an average force of 5.23kg |
| Tip Deflection Testing | Product straightens to -5° to 0° for cannula introduction/removal. | Passed (articulating from 0° to 90°) |
| Product articulates to ≥ 90° to allow positioning around the esophagus. | Passed (articulating from 0° to 90°) | |
| Lifecycle Testing | All 10 specimens to survive 2 irradiation cycles and 50 actuations (articulating from 0° to 90°) without any mechanical defects. | Passed (survived 2 irradiation cycles and 50 actuations without mechanical defects) |
| Drop Testing | Pass in accordance with pass criteria ASTM D4169-1996. After 100% inspection of product after dropping there should be no visible defects found in the product and the package seal should be intact. | Passed (packaging capable of maintaining device sterility and free from damage during transit) |
| Shelf Life (Accelerated Ageing) | Packaging seals meet ASTM F1886-98(2004), burst strength meets ASTM F1140-07, dye penetration meets ASTM F1929-98(2004) after accelerated aging equivalent to 5 years. | Not explicitly stated as "passed" for all specific tests but the report TN 100312 is provided, implying compliance. |
| Sterilization Validation | Achieve a SAL of 10⁻⁶ at a sterilization dose of 25 kilogray (validated in accordance with ANSI / AAMI / ISO 11137-2:2006, using the VDmax2 method). | Validation confirmed; 25 kilogray applied. |
| Biocompatibility - Cytotoxicity | Non-cytotoxic. | Indicated to be non-cytotoxic (negative control non-cytotoxic, positive control cytotoxic). |
| Biocompatibility - Sensitization | Non-sensitiser (stimulation of less than 3). | Considered to be a non-sensitiser (stimulation less than 3 for polar and non-polar extracts). |
| Biocompatibility - Intracutaneous Reactivity | Non-irritant (average reaction not greater than corresponding control). | Considered to be non-irritant (extracts meet ISO 10993-10:2002 requirements). |
2. Sample Size for the Test Set and Data Provenance
- Distal Tip Pull Testing: "13 samples" for production standard product. The provenance of the data is not specified (e.g., country of origin, retrospective/prospective), but it is implied to be laboratory bench testing.
- Lifecycle Testing: "All 10 specimens". The provenance of the data is not specified.
- Shelf Life (Accelerated Ageing): "Thirty test samples at each time point". The provenance of the data is not specified.
- Other tests do not explicitly state sample sizes but generally refer to "the LogiFlex laparoscopic band positioning device," implying testing on representative samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. The reported studies are nonclinical bench tests, not involving expert review for diagnostic purposes.
4. Adjudication method for the test set
- Not applicable. The reported studies are nonclinical bench tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. The provided text describes nonclinical bench tests.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical laparoscopic instrument, not an AI algorithm.
7. The type of ground truth used
- Ground truth was based on pre-defined engineering and safety specifications, as documented in technical notes and industry standards (e.g., ASTM, ISO). For example:
- Mechanical strength (tensile load, sideway force, pull out force).
- Articulation angles (-5° to 0°, ≥ 90°).
- Absence of mechanical defects.
- Maintenance of sterility and package integrity.
- Biocompatibility based on established biological response criteria (cytotoxicity, sensitization, irritation).
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not a machine learning model.
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k 100/09
SECTION 5:
510(k) SUMMARY
: JUL 1 5 2019
| Submitter: | Surgical Innovations plc.Clayton Wood House6 Clayton Wood BankLeedsLS16 6QZUnited KingdomTel.: +44 113 230-7597Fax: +44 113 230-7598 |
|---|---|
| Contact Person: | Mike WhiteProduct Development Director |
| Date SummaryPrepared: | 08 January 2010 |
| Trade Name: | LogiFlex Laparoscopic Band Positioning Device |
| Common Name: | Endoscope and accessories |
| Classification Name: | Laparoscope, General and Plastic Surgery(21 CFR 876.1500, Product Code GCJ). |
| Equivalent to: | Logic Monopolar Laparoscopic Scissors – Surgical Innovations plc(K063485).Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectorsand Needle Holders – Allegiance Healthcare Corporation (K991928).Goldfinger Blunt Dissector – Obtech Medical SARL(Class I, 510(k) exempt: 21 CFR 878.4800) |
11
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k 100109
The LogiFlex Laparoscopic Band Positioning Device is a sterile, single-use, Device Description: laparoscopic, blunt dissection instrument. It comprises a shaft with a distal articulating tip incorporating a slot that forms a hook for capturing suture threads and tubing. The LogiFlex Laparoscopic Band Positioning Device is designed to be connected to and used with the reusable, ratchet handle of the Logic Monopolar Laparoscopic Scissors in order to effect articulation of the distal tip. The LogiFlex Laparoscopic Band Positioning Device is not designed to be used with an electrocautery connection.
The LogiFlex Laparoscopic Band Positioning Device is indicated for use in Intended Use: laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to pull tubing and to generally assist with the placement of a gastric band.
Substantial Determination of substantial equivalence for the LogiFlex Laparoscopic Equivalence: Band Positioning Device was based on comparison to the predicate devices in terms of intended use, indications for use and device technological characteristics, such as design features, materials of composition, principle of operation and presentation. The LogiFlex Laparoscopic Band Positioning Device is substantially equivalent to the Logic Monopolar Laparoscopic Scissors and the Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders in terms of modularity of construction and intended use. The LogiFlex Laparoscopic Band Positioning Device is substantially equivalent to the single use insert components of the Logic Monopolar Laparoscopic Scissors in terms of the design, materials of construction, and principle of operation of the handle connection mechanism and the actuation mechanism. The LogiFlex Laparoscopic Band Positioning Device is substantially equivalent to the Goldfinger Blunt Dissector in terms of the indications for use and the design, materials of construction and principle of operation of the articulating distal tip.
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K100109
Nonclinical tests summary
1. Bench Testing
Distal Tip Pull Testing
For this test the input criteria was determined to be:
- . A tensile axial load > 2kg when pulling suture.
- Product straightens to -5° to 0° for cannula introduction / removal. �
- Product articulates to ≥ 90° to allow positioning around the esophagus. ●
The pass results in TN100309 (Exhibit 12) show that the pre-production LogiFlex laparoscopic band positioning device passes the input criteria, achieve a load of 2.96kg and articulating from 0° to 90°.
In TN100341 (Exhibit 16), further testing was carried out on production standard product (13 samples). The results show that the product has achieved a load of 2.6kg and articulating from 0° to 90°.
Sideway force testing
For this test the input criteria was determined to be:
- . A sideway force ≥ 0.54kg when pulling suture.
- . Product straightens to -5° to 0° for cannula introduction / removal.
- . Product articulates to ≥ 90° to allow positioning around the esophagus.
The pass results in TN100310 (Exhibit 11) show that the LogiFlex laparoscopic band positioning device passes the input criteria, achieve a sideway force of 0.54kg (same as Goldfinger Blunt Dissector) and articulating from 0° to 90°.
Crimped nipple pull out testing
For this test the input criteria was determined to be:
- Crimped nipple to withstand 5kg amount of force. .
The pass result in TN100341 (Exhibit 16) shows that the LogiFlex laparoscopic band positioning device passes the input criteria, achieving an average force of 5.23kg.
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K100109
Tip deflection testing
For this test the input criteria was determined to be:
- Product straightens to -5° to 0° for cannula introduction / removal. ●
- Product articulates to ≥ 90° to allow positioning around the esophagus. ●
The pass results in TN100341 (Exhibit 16) show that the LogiFlex laparoscopic band positioning device passes the input criteria to articulate from 0° to 90°.
Lifecycle testing
For this test the input criteria was determined to be:
- All 10 specimens to survive 2 irradiation cycles and 50 actuations (articulating from 0° to . 90°) without any mechanical defects.
The pass results in TN100326 (Exhibit 14) show that the LogiFlex laparoscopic band positioning device passes the input criteria to survive 2 irradiation cycles and 50 actuations without any mechanical defects.
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 there should be no visible defects found in the product and the package seal should be intact.
The pass results in TN 100311 (Exhibit 15) show that the LogiFlex laparoscopic band positioning device passes the input criteria where the packaging is capable of maintaining the device in a sterile condition and free from damage during transit.
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2. Shelf life: LogiFlex Accelerated Ageing Testing
A 5 year accelerated shelf life study is completed with the LogiFlex Laparoscopic Band Positioning Device. The study has been performed in accordance with ASTM F1980-07 and involves ageing of packed, sterilized devices at 53°C ± 4°C, under which conditions, 6 weeks storage duration is equivalent to 12 months storage at ambient temperature. Thirty test samples at each time point are subjected to visual inspection of the seals (in accordance with ASTM F1886-98(2004)); 15 of these are subjected to burst strength testing (in accordance with ASTM F1140-07) and 15 to dye penetration testing (in accordance with ASTM F1929-98(2004)). The full report of this testing (ref. Technical Note 100312) is provided at Exhibit 9.
3. Sterilization Validation
The gamma radiation sterilization process used for sterilization of the Logic Laparoscopic Band Positioning Device has been validated in accordance with ANSI / AAMI / ISO 11137-2:2006, using the VDmax2 method, and is subject to quarterly re-validation. To achieve a SAL of 10° a sterilization dose of 25kilogray must be applied to this product.
The full report of this testing (ref. Technical Note 100313) is provided at Exhibit 7.
4. Materials Biocompatibility
From ISO 10993-1:2002, LogiFlex is an external communicating device with duration < 24 hours, therefore initial tests for consideration are:
-
- Cytotoxicity
-
- Sensitization
- ന് Intracutaneous reactivity.
1. Cytotoxicity Test
The result has showed that the extract of the negative control (polypropylene filters) was noncytotoxic to 1929 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. Therefore, LogiFlex has been indicated to be non-cytotoxic.
The full report of this testing (ref. Technical Note 100314) is provided at Exhibit 10.
2. Local Lymph Node Assay in the mouse
The result has showed that a stimulation of less than 3 was recorded for the polar and non-polar extract of the test item. Therefore, the polar and non-polar extracts of LogiFlex were considered to be a non-sensitiser under the conditions of the test.
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3. Intracutaneous Reactivity test in the rabbit
The result has showed that the average reaction to the polar and non-polar test item extracts was considered not to be greater than the average reaction for the corresponding control at any observation period. Therefore, polar and non-polar extracts of the LogiFlex meet the requirements of ISO 10993-10:2002 Intracutaneous (Intradermal) Reactivity Test in the Rabbit; and considered to be non-irritant under the conditions of the test. .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The overall design is simple and recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 5 2010
Surgical Innovations Plc. % Mr. Mike White Product Development Director Clayton Wood House 6 Clayton Wood Bank Leeds LS16 60Z United Kingdom
Re: K100109
Trade/Device Name: LogiFlex Laparoscopic Band Positioning Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: July 07, 2010 Received: July 12, 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
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 (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/ucm115809.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 voll-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 yours.
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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Page 1 of ①
t 100109
SECTION 4:
INDICATIONS FOR USE STATEMENT
510{k) Number (if known): Not known
Device Name:
LogiFlex Laparoscopic Band Positioning Device
Indications for Use:
Use in laparoscopic procedures for blunt dissection between tissue layers, to pull suture threads, to manipulate tubing and to generally assist with the placement of a gastric band.
Prescription Use___X
AND/ OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concerns of the Region of Device Evaluation (ODE) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_
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.