(182 days)
Not Found
No
The device description and performance studies focus on mechanical properties, biocompatibility, and sterilization, with no mention of AI or ML.
No.
The device is described as a blunt dissection instrument and positions a gastric band, which are surgical assistance functions rather than therapeutic interventions that treat or cure a disease or condition.
No
The device is described as a "blunt dissection instrument" used for manipulation and placement during laparoscopic procedures. Its performance studies focus on mechanical properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is a "sterile, single-use, laparoscopic, blunt dissection instrument" comprising a shaft and distal tip, and describes physical bench testing, shelf life, sterilization, and biocompatibility studies, all indicative of a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures (laparoscopic procedures) involving blunt dissection, manipulating tissue and suture threads, and assisting with gastric band placement. This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The description details a surgical instrument with a shaft, articulating tip, and hook for manipulating objects during surgery. It's designed for physical interaction with tissues and materials within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties (strength, durability, articulation), shelf life, sterilization, and biocompatibility. These are typical evaluations for surgical instruments, not IVDs which would focus on analytical and clinical performance related to diagnosis.
- Predicate Devices: The predicate devices listed are all surgical instruments (laparoscopic scissors, forceps, dissectors, needle holders, blunt dissector).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural and manipulative within a surgical context.
N/A
Intended Use / Indications for Use
The LogiFlex Laparoscopic Band Positioning Device is indicated for use in 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.
Product codes
GCJ
Device Description
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.
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
- Bench Testing:
- Distal Tip Pull Testing: Input criteria: tensile axial load > 2kg, product straightens to -5° to 0° for cannula introduction/removal, articulates to >= 90° for esophageal positioning. Pre-production device achieved 2.96kg and articulated 0° to 90°. Production standard product (13 samples) achieved 2.6kg and articulated 0° to 90°.
- Sideway force testing: Input criteria: sideway force >= 0.54kg when pulling suture, product straightens to -5° to 0° for cannula introduction/removal, articulates to >= 90° for esophageal positioning. Device achieved 0.54kg and articulated 0° to 90°.
- Crimped nipple pull out testing: Input criteria: crimped nipple to withstand 5kg force. Device achieved an average force of 5.23kg.
- Tip deflection testing: Input criteria: product straightens to -5° to 0° for cannula introduction/removal, articulates to >= 90° for esophageal positioning. Device articulated 0° to 90°.
- Lifecycle testing: Input criteria: 10 specimens survive 2 irradiation cycles and 50 actuations (articulating 0° to 90°) without mechanical defects. Device met criteria.
- Drop testing: Input criteria: Pass in accordance with ASTM D4169-1996, no visible defects after 100% inspection, package seal intact. Device met criteria; packaging capable of maintaining device sterility and integrity during transit.
- Shelf life:
- LogiFlex Accelerated Ageing Testing: 5-year accelerated shelf life study (ASTM F1980-07), 6 weeks at 53°C equivalent to 12 months at ambient. 30 test samples per time point subjected to visual inspection of seals (ASTM F1886-98(2004)); 15 to burst strength testing (ASTM F1140-07); 15 to dye penetration testing (ASTM F1929-98(2004)).
- Sterilization Validation:
- Gamma radiation sterilization process validated in accordance with ANSI / AAMI / ISO 11137-2:2006, using VDmax2 method. Quarterly re-validation. SAL of 10-6 requires 25kilogray.
- Materials Biocompatibility (ISO 10993-1:2002 for external communicating device
§ 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.
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k 100/09
SECTION 5:
510(k) SUMMARY
: JUL 1 5 2019
| 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 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike White
Product Development Director |
| Date Summary
Prepared: | 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, Dissectors
and 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