(86 days)
Not Found
No
The document describes a set of mechanical surgical instruments and their functional and safety testing, with no mention of AI or ML capabilities.
No
The device is described as surgical instruments used for various manipulations of tissues and vessels during laparoscopic procedures, including cutting, grasping, and cauterizing, rather than directly treating a disease or condition.
No
The provided text describes the SPIDER® Surgical Instruments as tools for performing various manipulations of tissues and vessels during laparoscopic procedures, such as grasping, mobilizing, cutting, cauterizing, and ligating. There is no mention of the device being used to diagnose conditions or process diagnostic information.
No
The device description clearly outlines physical components like handles, shafts, and tips, and the performance studies detail testing of hardware aspects like sterility, biocompatibility, and electrical safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures." This describes a surgical tool used on the body, not a device used to examine specimens from the body.
- Device Description: The description details a surgical instrument with components like handles, shafts, and tips for manipulating tissue. It also mentions electrocautery for cutting and coagulation of tissue. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The SPIDER® Surgical Instruments are tools used directly in surgical procedures.
N/A
Intended Use / Indications for Use
The SPIDER® Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.
Product codes
GEI
Device Description
The SPIDER® Flexible Monopolar Instruments are surgical instruments used to facilitate laparoscopic surgery. The instruments are a part of the SPIDER® Flexible Surgical Instruments family. They are intended for use with the SPIDER® Single Port Device. The instruments may be used with or without electrocautery.
The flexible electrocautery instruments are pre-sterilized, single use, disposable devices. The devices have a ring handle with ratchets where applicable, a rotation knob for rotating the shaft and distal tips, an electrocautery post for cable connection to an electrosurgical generator, a flexible shaft, and distal tips to manipulate tissue. The instruments may be used without connecting to a power source. However, when connected by a standard cable to an electrosurgical generator, the instruments may be used for cutting and coagulation of tissue. The instrument set includes:
- Flexible graspers for grasping tissue
- Flexible shears for cutting tissue
- Flexible dissectors for dissecting tissue
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal
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)
The SPIDER® Flexible Monopolar Surgical Instruments have been functionally tested and found to perform their intended functions for laparoscopic surgical procedures as well as their electrocautery functions and have been tested for reliability. The devices have also been tested with the SPIDER® device and found to meet the internal acceptance criteria for system compatibility with the SPIDER® platform.
Gamma sterility testing has been conducted for the SPIDER® Flexible Instruments Family which includes the SPIDER® Flexible Monopolar Instruments and has been shown to achieve a sterility assurance level of 1x10 . The devices were verified as sterile via a dose audit study in accordance with ISO 11137-1, ISO 11137-2, and ISO 11137-3. In addition, the sterile barrier packaging has been tested for the SPIDER® Flexible Instruments family in accordance with ISO 11607-1 and 11607-2 and ASTM F1980-07 and has been found to maintain sterility during shelf life testing. The SPIDER® Flexible Monopolar Instruments have likewise been tested for functionality over time and have been found to maintain performance in accordance with the design specifications.
The SPIDER® Instruments have been tested for biocompatibility in accordance with ISO 10993-1 based on type and duration of contact to assure that they are non-cytoxic, nonirritating and non-sensitizing.
The SPIDER® Flexible Monopolar Instruments have been evaluated and/or tested for compliance to the medical electrical safety standards IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 and found to be compliant. The device insulation has also been tested using high potential test (HIPOT) and dielectric withstand testing to assure that the insulation maintains its properties and does not breakdown.
The SPIDER® Flexible Monopolar Surgical Instruments have been tested in a preclinical swine study to evaluate their performance and success in laparoscopic procedures. The study found that the SPIDER® Flexible Monopolar Instruments performed as intended. When compared to the predicate devices, the SPIDER® Flexible Monopolar Instruments do not incorporate any significant technological differences that affect safety and efficacy, therefore, clinical data was not deemed necessary for evaluation of substantial equivalence.
These verification and validation test results are sufficient to demonstrate safety and effectiveness compared to predicate devices used in standard laparoscopic surgical techniques. Any minor technological differences in the design or materials of the SPIDER® Surgical Instruments have been evaluated and found to present no new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image shows the logo for TransEnterix, a medical technology company. The logo features a stylized letter "T" with a horizontal line above it, followed by the word "ransEnterix" in a modern sans-serif font. Below the company name is the tagline "advancing surgery through innovation" in a smaller font, with trademark symbols next to both the company name and the tagline.
OCT 2 5 2012
K122299 - 510(k) Summary
This summary of safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 27, 2012
| 1. | Submitter: | |||
|---|---|---|---|---|
| Submitted by: | TransEnterix, Inc. | |||
| 635 Davis Drive, Suite 300 | ||||
| Durham, NC 27713 | ||||
| TEL: 919-765-8420 | ||||
| FAX: 919-765-8459 | ||||
| Contact: | Tammy Carrea | |||
| VP Quality and Regulatory Affairs | ||||
| 2. | Device: | |||
| Propriety Name | SPIDER® Flexible Surgical Instruments: | |||
| Flex Monopolar Graspers, Wavy Ratcheted | ||||
| Flex Monopolar Graspers, Serrated Ratcheted | ||||
| Flex Monopolar Maryland Dissectors | ||||
| Flex Monopolar Shears | ||||
| Common Name | Electrosurgical Monopolar Surgical Instrument | |||
| Classification Name: | Electrosurgical cutting and coagulation device and | |||
| accessories | ||||
| Classification: | Class II, 21 CFR 878.4400 | |||
| Product Code: | GEI | |||
3. Predicate Devices:
| Class | Manufacturer | 510(k) Number | Device Name/Description |
|---|---|---|---|
| II | TransEnterix | K091697 | |
| K102646 | SPIDER® Flexible Instruments: Maryland | ||
| Dissector, Graspers (Blunt nose), Shears | |||
| II | Covidien | K091869 | SILS™ Clincher, Graspers, Dissector, |
| Shears |
4. Description:
The SPIDER® Flexible Monopolar Instruments are surgical instruments used to facilitate laparoscopic surgery. The instruments are a part of the SPIDER® Flexible Surgical
1
Instruments family. They are intended for use with the SPIDER® Single Port Device. The instruments may be used with or without electrocautery.
The flexible electrocautery instruments are pre-sterilized, single use, disposable devices. The devices have a ring handle with ratchets where applicable, a rotation knob for rotating the shaft and distal tips, an electrocautery post for cable connection to an electrosurgical generator, a flexible shaft, and distal tips to manipulate tissue. The instruments may be used without connecting to a power source. However, when connected by a standard cable to an electrosurgical generator, the instruments may be used for cutting and coagulation of tissue. The instrument set includes:
- . Flexible graspers for grasping tissue
- Flexible shears for cutting tissue .
- Flexible dissectors for dissecting tissue .
5. Indications for Use:
The SPIDER® Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.
6. Comparison of Technological Characteristics with Predicate:
The SPIDER® Flexible Monopolar Surgical Instruments have the same intended use and function of other currently marketed laparoscopic and endoscopic surgical instruments, specifically the SPIDER® Surgical Instruments cleared in K091697. Like the predicates the instruments have the same or similar end effector/jaw/tip designs. The devices achieve the same function using the same modes of action. The flexible instruments are passed through the SPIDER®'s instrument delivery tubes (IDTs) and advanced to the surgical site in exactly in the same manner as other previously cleared SPIDER® surqical instruments.
The SPIDER® Flexible Monopolar Instruments utilize the same or similar design. dimensions, materials of construction, packaging and sterilization as that of the SPIDER® Surgical Instruments in K091697. Similar to the predicate devices the SPIDER® Flexible Monopolar Instruments are provided pre-sterilized, are disposable, and are single use devices.
The electrocautery features of the SPIDER® Flexible Monopolar Surgical Instruments are similar to those of the SILS™ Dissector and Shears from K091869. Both device designs are monopolar and include a post for cable connection to an electrosurgical generator. Both device designs are utilized with single port laparoscopic access systems.
Any technological differences between the SPIDER® Flexible Monopolar Surgical Instruments and the predicates have been mitigated via testing. The SPIDER® Flexible Monopolar Surgical Instruments do not introduce any new issues of safety or effectiveness compared to other similar laparoscopic surgical devices currently marketed.
2
7. Performance Data:
The SPIDER® Flexible Monopolar Surgical Instruments have been functionally tested and found to perform their intended functions for laparoscopic surgical procedures as well as their electrocautery functions and have been tested for reliability. The devices have also been tested with the SPIDER® device and found to meet the internal acceptance criteria for system compatibility with the SPIDER® platform.
Gamma sterility testing has been conducted for the SPIDER® Flexible Instruments Family which includes the SPIDER® Flexible Monopolar Instruments and has been shown to achieve a sterility assurance level of 1x10 . The devices were verified as sterile via a dose audit study in accordance with ISO 11137-1, ISO 11137-2, and ISO 11137-3. In addition, the sterile barrier packaging has been tested for the SPIDER® Flexible Instruments family in accordance with ISO 11607-1 and 11607-2 and ASTM F1980-07 and has been found to maintain sterility during shelf life testing. The SPIDER® Flexible Monopolar Instruments have likewise been tested for functionality over time and have been found to maintain performance in accordance with the design specifications.
The SPIDER® Instruments have been tested for biocompatibility in accordance with ISO 10993-1 based on type and duration of contact to assure that they are non-cytoxic, nonirritating and non-sensitizing.
The SPIDER® Flexible Monopolar Instruments have been evaluated and/or tested for compliance to the medical electrical safety standards IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 and found to be compliant. The device insulation has also been tested using high potential test (HIPOT) and dielectric withstand testing to assure that the insulation maintains its properties and does not breakdown.
The SPIDER® Flexible Monopolar Surgical Instruments have been tested in a preclinical swine study to evaluate their performance and success in laparoscopic procedures. The study found that the SPIDER® Flexible Monopolar Instruments performed as intended. When compared to the predicate devices, the SPIDER® Flexible Monopolar Instruments do not incorporate any significant technological differences that affect safety and efficacy, therefore, clinical data was not deemed necessary for evaluation of substantial equivalence.
These verification and validation test results are sufficient to demonstrate safety and effectiveness compared to predicate devices used in standard laparoscopic surgical techniques. Any minor technological differences in the design or materials of the SPIDER® Surgical Instruments have been evaluated and found to present no new issues of safety and effectiveness.
Conclusion: 8.
The conclusion drawn from the test data is that the SPIDER® Flexible Monopolar Surgical Instruments are as safe and effective as the predicate devices, have the same intended use as the predicates, perform similarly to other legally marketed predicate devices for laparoscopic surgery, and do not raise any new issues of safety or effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Transenterix, Incorporated % Ms. Tammy B. Carrea Vice President, Quality and Regulatory Affairs 635 Davis Drive, Suite 300 Durham, North Carolina 27713
OCT 25 2012
Re: K12299
Trade/Device Name: SPIDER®(Single Port Instrument Delivery Extended Reach) Surgical Instruments
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 27, 2012 · Received: July 31, 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 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
4
Page 2 - Ms. Tammy B. Carrea
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 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
K122299 510(k) No.
If known
Indications For Use Statement
Device Name:
SPIDER® (Single Port Instrument Delivery Extended Reach) Surgica! Instruments
Indications For Use:
The SPIDER® Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.
Neil R. P. Ogden for nxm
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K122299 | ||
|---|---|---|---|
| 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 NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | 1122259 |
|---|---|
| --------------- | --------- |