(67 days)
Not Found
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI or ML.
No.
This device is a surgical instrument used to assist in laparoscopic procedures by dissecting tissue and facilitating the placement of gastric bands, rather than directly providing therapy.
No
The device is described as a surgical instrument used to dissect tissue, pull tubing, and assist in placing gastric bands during laparoscopic surgery. These are interventional/therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a physical surgical instrument with a flexible shaft, articulating tip, handle, and retractable loop. The performance studies also focus on the mechanical and material properties of the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The SPIDER® Flexible Blunt Dissector and Band Passer is a surgical instrument used during laparoscopic surgery to manipulate tissue and assist in placing gastric bands within the body. It is a tool for performing a surgical procedure, not for analyzing biological samples.
- Intended Use: The intended use clearly describes its function in a surgical setting, not in a laboratory or for diagnostic testing of specimens.
- Device Description: The description details its physical characteristics and how it's used as a surgical tool.
- Performance Studies: The performance studies focus on the device's mechanical function, sterility, biocompatibility, and performance in simulated and cadaveric surgical settings. There are no studies related to analyzing biological samples or providing diagnostic information.
Therefore, the SPIDER® Flexible Blunt Dissector and Band Passer is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SPIDER® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.
Product codes
GCJ
Device Description
The SPIDER® Flexible Blunt Dissector and Band Passer device is a surgical instrument used to facilitate laparoscopic surgery. It is intended for use with the SPIDER® Single Port Device or other laparoscopic access device that facilitates the use of rigid and/or flexible instrumentation.
The SPIDER® Flexible Blunt Dissector and Band Passer instrument has a flexible shaft with an articulating distal tip is blunt to allow tissue dissection between tissue layers and the articulation is actuated via a proximal ratcheted handle. The blunt tip includes a shallow slot to grab sutures as applicable. It also includes a non-electrical retractable loop (grasping loop) for grasping and pulling tubing, sutures, or tissue. The instrument is provided sterile and is a single use, disposable device.
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
Functional testing of the SPIDER® Flexible Blunt Dissector and Band Passer device was conducted during bench studies to evaluate the articulation angle, strength, function of the blunt tip, function of loop, cycle testing for reliability, and was tested under simulated use conditions. The simulated use testing was conducted by testing the instrument with the SPIDER® laparoscopic device and tissue samples (chicken tissue). The study found that the SPIDER® Flexible Blunt Dissector and Band Passer device performed as a intended and remained functional following cycle testing.
Gamma sterility testing has been conducted for the SPIDER® Flexible Instruments Family which includes the Blunt Dissector and Band Passer device and has been shown to achieve a sterility assurance level of 1x10 °. In addition the sterile barrier packaging has been tested for the Flexible Instruments family and has been found to maintain sterility during shelf life testing.
The SPIDER® Flexible Blunt Dissector and Band Passer device has been tested for biocompatibility in accordance with ISO 10993-1 based on the duration of contact and type of contact. The studies concluded that the instruments are non-toxic, non-irritating, and non-sensitizing.
Pre-clinical testing in a cadaver model study was performed and demonstrated that the SPIDER® Flexible Blunt Dissector and Band Passer device compares to that of standard laparoscopic instruments and predicate devices in terms of performing blunt dissection and band positioning in laparoscopic procedures.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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APR 1 6 2012
Image /page/0/Picture/1 description: The image shows the word "TransEnterix" in a stylized font. The first part of the word, "Trans", is in a bold, sans-serif font, while the second part, "Enterix", is in a thinner, sans-serif font. There is a trademark symbol after the word.
advancing surgery through innovation™
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510(k) Summarv
20403
This summary of safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: April 11, 2012
-
- Submitter:
Submitted by:
- Submitter:
TransEnterix, Inc. 635 Davis Drive, Suite 300 Durham, NC 27713 TEL: 919-765-8420 FAX: 919-765-8459
VP Quality and Regulatory Affairs
Contact:
- Device:
| Propriety Name | SPIDER® Flexible Blunt Dissector and Band Passer |
|---|---|
| Common Name | Laparoscopic instrument and accessory |
| Classification Name: | Endoscope and accessories |
| Classification: | Class II 21 CFR 876.1500 |
| Product Code: | GCJ |
Tammy Carrea
3. Predicate Devices:
| Class: | 510(k) Number: | Device Name/Description: |
|---|---|---|
| II | K100109 | Logiflex Laparoscopic Band Positioning Device |
| I | None | Realize Blunt Dissector (previously known as the |
| Obtech Medical Goldfinger Blunt Dissector) | ||
| II | K091697 | SPIDER Flexible Grasper |
4. Description:
The SPIDER® Flexible Blunt Dissector and Band Passer device is a surgical instrument used to facilitate laparoscopic surgery. It is intended for use with the SPIDER® Single Port Device or other laparoscopic access device that facilitates the use of rigid and/or flexible instrumentation.
The SPIDER® Flexible Blunt Dissector and Band Passer instrument has a flexible shaft with an articulating distal tip is blunt to allow tissue dissection between tissue layers and the articulation is actuated via a proximal ratcheted handle. The blunt
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1
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tip includes a shallow slot to grab sutures as applicable. It also includes a non-electrical retractable loop (grasping loop) for grasping and pulling tubing, sutures, or tissue. The instrument is provided sterile and is a single use, disposable device.
5. Indications for Use:
The SPIDER® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.
6. Comparison of Technological Characteristics with Predicate:
The SPIDER® Flexible Blunt Dissector and Band Passer device utilizes the same or similar design, dimensions, materials of construction, and sterilization as that of the i SPIDER Flexible Grasper. The flexible design and length of the SPIDER® Flexible Blunt Dissector and Band Passer device is essentially the same as the SPIDER® Flexible Grasper currently marketed.
Similar to the predicate devices the SPIDER® Flexible Blunt Dissector and Band Passer device is provided pre-sterilized, is disposable, and is a single use device, the same as other predicate devices.
The SPIDER® Blunt Dissector and Band Passer device has a blunt tip to facilitate tissue dissection and an articulating distal tip similar to the gastric band predicate devices. All of the devices include a slot to capture and pull a suture. The only technological difference in the SPIDER® Flexible Blunt Dissector and Band Passer device and the gastric band predicate devices is the mechanical mechanism for grabbing a band. The Logiflex Band Positioning Device and the Realize Blunt Dissector (Goldfinger) use a large open slot to capture the band. The SPIDER® Flexible Blunt Dissector and Band Passer device uses a retractable mechanical loop that can be deployed to grab and pull bands. This technological feature has been tested in simulated use bench studies and in a cadaver model to demonstrate that it fulfills its intended use with regard to grabbing and pulling bands.
Any technological differences between the SPIDER® Flexible Blunt Dissector and Band Passer device and the predicates have been mitigated via functional, simulated use, and preclinical testing. Thus the SPIDER® Flexible Blunt Dissector and Band Passer device does not introduce any new issues of safety or effectiveness compared to other similar laparoscopic or endoscopic surgical devices currently marketed.
7. Performance Data:
Functional testing of the SPIDER® Flexible Blunt Dissector and Band Passer device was conducted during bench studies to evaluate the articulation angle, strength, function of the blunt tip, function of loop, cycle testing for reliability, and was tested under simulated use conditions. The simulated use testing was conducted by testing the instrument with the SPIDER® laparoscopic device and tissue samples (chicken tissue). The study found
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120403
Page 3 of 3
that the SPIDER® Flexible Blunt Dissector and Band Passer device performed as a intended and remained functional following cycle testing.
Gamma sterility testing has been conducted for the SPIDER® Flexible Instruments Family which includes the Blunt Dissector and Band Passer device and has been shown to achieve a sterility assurance level of 1x10 °. In addition the sterile barrier packaging has been tested for the Flexible Instruments family and has been found to maintain sterility during shelf life testing.
The SPIDER® Flexible Blunt Dissector and Band Passer device has been tested for biocompatibility in accordance with ISO 10993-1 based on the duration of contact and type of contact. The studies concluded that the instruments are non-toxic, non-irritating, and non-sensitizing.
Pre-clinical testing in a cadaver model study was performed and demonstrated that the SPIDER® Flexible Blunt Dissector and Band Passer device compares to that of standard laparoscopic instruments and predicate devices in terms of performing blunt dissection and band positioning in laparoscopic procedures.
Conclusion: 8.
The conclusion drawn from the test data is that the SPIDER® Flexible Blunt Dissector and Band Passer is as safe and effective as the predicate devices, has the same intended use and performs similarly to other legally marketed predicate devices for laparoscopic surgery, and does not raise any new issues of safety or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, conveying the department's role in serving the American people.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TransEnterix, Inc. % Ms. Tammy B. Carrea VP Quality and Regulatory Affairs 635 Davis Drive, Suite 300 Durham, North Carolina 27713
Re: K120403
Trade/Device Name: SPIDER® (Single Port Instrument Delivery Extended Reach) Blunt Dissector and Band Passer device
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 8, 2012 Received: February 9, 2012
Dear Ms. Carrea:
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.
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
APR 1 6 2012
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Page 2 - Ms. Tammy B. Carrea
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/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 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 yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) No. K120403
If known
Indications For Use Statement
Device Name:
SPIDER® (Single Port Instrument Delivery Extended Reach) Blunt Dissector and Band Passer device
Indications For Use:
The SPIDER® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.
Prescription Use
AND/OR '
x
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 NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nish R.P. Dasler for nxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120403