The SPIDER Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.

Device Description

The Flex Monopolar Hook is a pre-sterilized, single use, disposable, electrosurgical device. These devices are gamma sterilized.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, as it pertains to acceptance criteria and the study that proves the device meets those criteria:

Device: SPIDER™ Surgical Instruments, Flex Monopolar Hook

The provided document is a 510(k) summary for a medical device seeking clearance, not an AI/software device. Therefore, the questions related to AI-specific metrics, ground truth, expert consensus, and training/test sets for AI models are not applicable to this document. The document describes the safety and effectiveness testing for a physical surgical instrument.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a physical surgical instrument and not an AI device, the "acceptance criteria" are tied to performance standards and biocompatibility. The summary doesn't present a formal table with quantitative acceptance criteria in the way one would for an AI model's accuracy, sensitivity, or specificity. Instead, it describes compliance with recognized standards and successful outcomes in functional, biocompatibility, and other performance tests.

Acceptance Criteria Category	Specific Standard/Test Name (as mentioned)	Reported Device Performance	Comments
Functional Performance	Bench top simulation studies	Found to perform its intended function for laparoscopic surgical procedures (grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation, manipulation).	Included passing instruments through IDTs, manipulation within SPIDER, evaluation of instrument interference, ability to cauterize.
	Preclinical animal study	Evaluated system performance to ensure ability to perform intended clinical function, using all instruments and the SPIDER device together.	No specific numerical results are provided, but the outcome is stated as successful.
Biocompatibility	ISO 10993-1:2003	Conducted in accordance with standards for external communicating devices, exposure ≤ 24 hours.	No specific adverse reactions or failures reported.
	ISO 10993-5:1999 (Cytotoxicity)	Conducted in accordance with standards.	No specific adverse reactions or failures reported.
	ISO 10993-10:2002/A1:2006 (Irritation/Hypersensitivity)	Conducted in accordance with standards.	No specific adverse reactions or failures reported.
	ISO 10993-12:2007 (Sample Preparation)	Conducted in accordance with standards.	No specific adverse reactions or failures reported.
Sterilization	ISO 11137-1:2006	Validated gamma process maintaining a Sterility Assurance Level (SAL) of 1x10⁻⁶.	Based on determination of bioburden.
	ISO 11137-2:2007	Conducted to establish sterilization dose.	No specific failures reported.
Packaging Validation	ISO 11607-1:2006	3-lot packaging validation was successful.	Assured consistency of the packaging process.
	ISO 11607-2:2006	Conducted for validation requirements.	No specific failures reported.
Shelf Life	ISO 11607-1 & 11607-2, ASTM F1980-07	Accelerated and real-time shelf life studies conducted.	No specific failures reported due to sterilization change.
Transit Testing	ASTM D 4169-05	Conducted in accordance with standards.	No specific failures reported.
	ISTA Project 2A Series (2008)	Conducted in accordance with standards.	No specific failures reported.
	ASTM F 2096-04 (Gross Leaks)	Conducted in accordance with standards.	No specific failures reported.
	ASTM F 88-09 (Seal Strength)	Conducted in accordance with standards.	No specific failures reported.
Electrical Safety	IEC 60601-1	Performed according to related sections.	No specific failures reported.
	IEC 60601-1-2	Performed according to related sections.	No specific failures reported.
	IEC 60601-2-2	Performed according to related sections.	No specific failures reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated with a numerical value for each test. For packaging validation, it mentions a "3 lot packaging validation." For the animal study, the number of animals or trials is not specified. For benchtop testing, "simulation studies" are mentioned, implying multiple tests, but no size is given.
Data Provenance: Not specified (e.g., country of origin). The testing described is primarily laboratory-based ("bench top simulation studies," "preclinical animal study," "biocompatibility testing," "sterilization validation," "packaging validation," "shelf life studies," "transit testing," "electrical safety testing"). These are prospective tests conducted by the manufacturer or accredited labs to assess the device's conformance to standards and functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As a physical surgical instrument, "ground truth" in the context of expert review for diagnostic accuracy (common in AI/imaging devices) is not relevant here. The "truth" is established by direct measurement against engineering specifications, functional performance during simulations/animal use, and adherence to recognized international standards for safety and performance (e.g., ISO, ASTM, IEC).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert opinions, typically for establishing ground truth in diagnostic studies. This is not reported as relevant for the functional and safety testing of this physical device.

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 is an AI/software-specific study design. This document pertains to a physical surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This question relates to AI algorithm performance. This document pertains to a physical surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. For this physical device, "ground truth" is defined by:
- Functional Performance: Successful execution of intended actions (grasping, cutting, cauterizing, etc.) in benchtop and animal models.
- Compliance with Standards: Meeting the requirements and specifications outlined in various ISO, ASTM, and IEC standards (e.g., a Sterility Assurance Level of 1x10⁻⁶, biocompatibility profile, electrical safety parameters).
- Predicate Device Equivalence: Demonstrating that the device performs "as safe and effective as the predicate device" through direct comparison of design, materials, and performance in these tests.

8. The sample size for the training set

Not Applicable. This question relates to AI algorithm training data. This document pertains to a physical surgical instrument and does not involve a training set.

9. How the ground truth for the training set was established

Not Applicable. This question relates to AI algorithm training data. This document pertains to a physical surgical instrument and does not involve establishing ground truth for a training set.

Summary

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K102646
NOV - 3 2010

510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h).

Date: October 13, 2010

Submitter:

TransEnterix, Inc. 635 Davis Drive Suite 300 Morrisville, NC 27560

Bobbi L. Hadersbeck, M.S. Contact: Sr. Regulatory Affairs and Compliance Specialist

Phone: (919) 765-8400 x 8554 (919) 765-8459 Fax:

Propriety Name	SPIDER™ Surgical Instruments
Common Name	Laparoscopic instrument and accessory
Classification Name:	Endoscope and accessories
Classification:	Class II 21 CFR 876.1500
Product Code:	GCJ

Predicate Device(s):

TransEnterix, Inc. K091697 SPIDER ™ Surgical Instruments, Flex Monopolar Hook

Device Description:

The Flex Monopolar Hook is a pre-sterilized, single use, disposable, electrosurgical device. These devices are gamma sterilized.

Indications for Use:

The SPIDER™ Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.

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Comparison of Technological Characteristics with Predicate:

The SPIDER™ Flex Monopolar Hook has the same intended use and function of the predicate device. Like the predicate, the device has the same end effecter/tip design. The devices achieve the same function using the same modes of action. The modified device and predicate device are passed through the TransEnterix cannulas (IDTs) and advanced to the surgical site in exactly in the same manner.

The devices utilize the same or similar design, dimensions, and materials of construction. The design of the modified and predicate devices, in terms of length, tip size, and flexibility are the same and achieve access to the surgical space and perform their intended functions in a similar manner. Slight differences in dimensions do not present any new issues of safety or efficacy.

Both the modified and the predicate device are provided pre-sterilized, are disposable, and are single use devices. While the predicated device was ethylene oxide sterilized, the modified device is gamma sterilized.

Any technological differences between the modified device and the predicate has been mitigated via testing. Thus the SPIDER™ Flex Monopolar does not introduce any new issues of safety or effectiveness compared to other similar laparoscopic or endoscopic surgical devices currently marketed.

Performance Data:

The SPIDER™ Flex Monopolar Hook has been functionally tested in bench top simulation studies and found to perform its intended function for laparoscopic surgical procedures. The functional testing included passing flexible instruments through the SPIDER device's instrument delivery tubes, manipulation of the instruments within the SPIDER, evaluation of instrument interference, evaluation of the instrument function i.e. ability to cauterize, etc. In addition a preclinical animal study evaluated the system performance to ensure the ability to perform the intended clinical function. The preclinical study evaluated all instruments and the SPIDER device while used together.

Biocompatibility testing was conducted in accordance with the following standards for an external communicating device in contact with tissue/bone/dentin with an exposure time of 24 hours or less:

· ISO 10993-1:2003 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
· ISO 10993-5:1999 Biological Evaluation of Medical Devices Part 5: Tests for in vitro cytotoxicitv
· ISO 10993-10:2002 and 10993-10:2002/A1:2006 Biological Evaluation of Medical Devices- Part 10: Tests for irritation and delayed type hypersensitivity

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ISO 10993-12:2007 Biological Evaluation of Medical Devices Part 12: Sample preparation and reference.
The sterilization process was validated and based on determination of bioburden. The sterilization validation confirmed that the gamma process maintained a sterility assurance level (SAL) of 1x10 °. :
· ISO11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2007 Sterilization of health care products Radiation Part 2: . Establishing the sterilization dose.

Although sterile packaging did not change, a packaging validation was performed in accordance with the following standards to assure consistency of the packaging process. The 3 lot packaging validation was successful.

ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 2: . Validation requirements for forming, sealing, and assembly processes.

Lastly, in consideration of the sterilization change from EO to gamma, shelf life studies, both accelerated and real time, were conducted in accordance with ISO 11607-1 and 11607-2 and ASTM F1980-07, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices".

In addition, transit testing was conducted in accordance with the following standards:

ASTM D 4169-05 Performance Testing of Shipping Containers and Systems.* .
ISTA Project 2A Series (2008) Partial-Simulation Performance Test Procedure . Packaged Products 150lb or less.
ASTM F 2096-04 Standard Test Method for Detecting Gross Leaks in Porous . Medical Packaging by Internal Pressurization (Bubble Leak).*
ASTM F 88-09 Standard Test Method for Seal Strength of Flexible Barrier . Materials.*

Electrical safety testing was performed according to related sections of the following standards:

IEC 60601-1: Medical Electrical Equipment-part 1: General requirements for basic . safety and essential performance
IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for . safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-2: Medical electrical equipment Part 2-2: Particular requirements for . the safetv of high frequency surgical equipment

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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:

The conclusion drawn from the test data is that the modified SPIDER™ Flex Monopolar Hook is as safe and effective as the predicate device, perform similarly to the predicate devices for laparoscopic surgery, and does not raise any new issues of safety or effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

TransEnterix, Inc. % Ms. Bobbi L. Hadersbeck, M.S. Senior Regulatory Affairs and Compliance Specialist 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560

NOV - 3 2010

Re: K102646

Trade/Device Name: SPIDER™ Surgical Instruments, Flex Monopolar Hook Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: October 13, 2010 Received: October 14, 2010

Dear Ms. Hadersbeck:

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 - Ms. Bobbi L. Hadersbeck. M.S.

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 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

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NOV - 3 2010

Indications For Use Statement

Device Name: SPIDER™ Surgical Instruments, Flex Monopolar Hook

Intended Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 C.F.R. 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Hut the Ischen for nxm.
(Division Sign-Off)

(Optional Format 1-2-96)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102646

Regulation Number and Section

§ 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.