iDrive™ Powered Handle: The iDrive™ Powered Handle, when used with the iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
iDrive™ RALC: The iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

Device Description

Surgical stapler with Powered Handle, delivering implantable titanium staples. The iDrive™ Powered Handle with the iDrive™ Right Angle Linear Cutter delivers 2 rows of surgical staples on each side of the cutting blade, initiated by buttons on the powered handle.

AI/ML Overview

The provided document is a 510(k) summary for a surgical stapler system (iDrive™ System), which describes the device, its intended use, and performance data from in-vitro and in-vivo testing. However, it does not contain specific acceptance criteria values or detailed study results in numerical format that would directly enable me to fill out a table of acceptance criteria and reported performance with numerical values.

The document lists various performance tests conducted, but it doesn't provide the quantitative acceptance criteria for each test or the specific quantitative results achieved by the device against those criteria. For example, it lists "Staple line pull-apart strength test" but doesn't state what the minimum acceptable pull-apart strength was or what the device's measured pull-apart strength was.

Therefore, I cannot generate the table requested in point 1 or provide detailed answers to points 2, 3, 4, 5, 6, 7, 8, and 9 as they pertain to specific quantitative study outcomes and methodologies that are not present in this summary.

Based on the information provided in the 510(k) summary, here's what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Available in Document: The document lists various performance tests but does not provide specific numerical acceptance criteria or the quantitative results achieved by the device for these tests. Therefore, a table with these details cannot be generated from the provided text.

Acceptance Criteria (e.g., Min. Pull-Apart Strength)	Reported Device Performance (e.g., Measured Pull-Apart Strength)
Not specified in document	Not specified in document
e.g., Staple formation: >95% acceptable formation	e.g., Staple formation: X% acceptable formation
e.g., Burst strength: Minimum X mmHg without leak	e.g., Burst strength: Y mmHg without leak
...and so on for listed tests	...and so on for listed tests

2. Sample Size Used for the Test Set and Data Provenance

Information Not Available in Document: The document mentions "In-vitro and in-vivo testing" but does not specify the sample sizes used for any of the tests listed (e.g., number of staple lines tested, number of animals in in-vivo studies, etc.). The provenance of the data (e.g., country of origin) is also not stated beyond being internal Covidien testing. The document is a regulatory submission, implying the studies were conducted by the manufacturer. Whether the studies were retrospective or prospective is not explicitly mentioned, but performance testing is typically prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Information Not Available in Document: The document does not describe the use of human "experts" to establish ground truth in the context of these performance tests. These are engineering and biological performance tests, not diagnostic image interpretation.

4. Adjudication Method for the Test Set

Information Not Available in Document: Adjudication methods (like 2+1, 3+1) are relevant to situations where subjective interpretation or consensus among multiple human reviewers is required (e.g., clinical trials with expert readers assessing outcomes). This is not applicable to the engineering and biological performance tests described in the 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Information Not Available in Document: An MRMC comparative effectiveness study, typically comparing human readers with and without AI assistance, is not mentioned. The device is a surgical stapler, not an AI or imaging diagnostic device where such studies are common.

6. Standalone (Algorithm Only) Performance Study

Information Not Available in Document: This question is relevant to AI algorithms. The device is a physical surgical stapler system, not an algorithm, so a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

For the performance tests listed:

Staple line pull-apart strength test: Actual measured mechanical strength.
Staple formation test: Visual and/or microscopic assessment against defined criteria for properly formed staples.
Staple line burst strength test: Pressure required to cause a leak in a stapled tissue sample.
Hemostasis (free bleed time) evaluation: Time to cessation of bleeding after stapling in in-vivo models.
Air leak test: Presence or absence of air leakage.
Tissue trauma evaluation: Histopathological assessment of tissue damage in in-vivo models.
Knife Cutting Performance test: Assessment of cut quality, completeness, and effort.
Product security on Tissue test while clamping and firing: Observational and/or force-based assessment of device stability and tissue retention.
Autoclave Reliability test: Functional performance after sterilization cycles.
Egress of material test: Gravimetric or qualitative assessment of material release.
Fire and clamp Shaft peak stall output torque measurement: Mechanical force measurements.
Battery and Battery charger tests: Electrical and functional performance of power components.

The "ground truth" for these tests would be the objective physical or biological measurements and observations against pre-defined engineering and biological specifications.

8. Sample Size for the Training Set

Not Applicable / Information Not Available in Document: This question refers to machine learning algorithms. The iDrive™ System is a mechanical device, not an AI system that requires a "training set" in the machine learning context. All tests described are performance and safety evaluations, not data used for model training.

9. How the Ground Truth for the Training Set was Established

Not Applicable / Information Not Available in Document: As explained in point 8, there is no "training set" for this type of device.

Summary

{0}------------------------------------------------

Covidien IIc (formerly registered as Tyco Healthcare, LP)

K102325
pg 1 of 2

OCT 1 3 2010

510(k) Summary of Safety and Effectiveness

SUBMITTER: Covidien IIc (formerly registered as Tyco Healthcare, LP) 60 Middletown Avenue North Haven, CT 06473 Tel. No .: (203) 492-5000

CONTACT PERSON: Nishith Desai Associate Manager, Regulatory Affairs Covidien IIc Phone: (203) 492-6339 Fax: (203) 492- 5029

August 16, 2010 DATE PREPARED:

TRADE/PROPRIETARY NAME: iDrive™ System

COMMON/USUAL NAME: Implantable, Staple

Surgical devices - Staple, Implantable CLASSIFICATION NAME:

Covidien, iDriveC (K073001) PREDICATE DEVICE(S): Covidien, RALC (K012809) Ethicon, CONTOUR Curved Cutter Stapler (K091322) Covidien, Autosuture TA DST Series Stapler (K013860, K801589)

Surgical stapler with Powered Handle, delivering implantable DEVICE DESCRIPTION: titanium staples.

INTENDED USE:

TECHNOLOGICAL

MATERIALS:

CHARACTERISTICS:

iDrive™ Powered Handle

The Covidien iDrive™ Powered Handle, when used with the Covidien™ iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

iDrive™ RALC

The Covidien iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the Covidien™ iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

The iDrive™ Powered Handle with the iDrive™ Right Angle Linear Cutter delivers 2 rows of surgical staples on each side of the cutting blade, initiated by buttons on the powered handle.

All patient-contacting components of the iDrive™ Powered Handle and iDrive™ Right Angle Linear Cutter are comprised of materials that have been evaluated in accordance with ISO

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<102325
pg 2 of 2

10993-1: 2003, Biological Evaluation of medical devices -- Part 1: Evaluation and Testing.

PERFORMANCE DATA:

In-vitro and in-vivo testing to support the intended use of this device includes:

Staple line pull-apart strength test 0
Staple formation test o
Staple line burst strength test 0
Hemostasis (free bleed time) evaluation 0
Air leak test 0
Tissue trauma evaluation O
Knife Cutting Performance test 0
ಂ Product security on Tissue test while clamping and firing
o Autoclave Reliability test
O Egress of material test
Fire and clamp Shaft peak stall output torque o measurement
Battery and Battery charger tests O

Additional bench top testing has been performed and includes testing to the following electrical safety standards:

IEC 60601-1: 1988 + A1 (1991) + A2 (1995) o
IEC 60601-1-2: 2007 o
IEC 60601-1-8: 2006 o

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head.

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

Covidien, LLC % Nishith Desai Associate Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K102325

Trade/Device Name: iDrive™ System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: August 16, 2010 Received: August 17, 2010

OCT 1 3 2010

Dear Nishith Desai:

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

{3}------------------------------------------------

Page 2 - Nishith Desai

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/ReportalProblem/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,

Er
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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Indications for Use

K102325 510(k) Number (if known):

Device Name:

OCT 1 3 2010

Indications For Use

iDrive™ Powered Handle

The iDrive™ Powered Handle, when used with the iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

iDrive™ RALC

The iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krone for WXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of

510(k) Number K102325

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.