(24 days)
The Ethicon Endo-Surgery® 5mm Laparoscopic Multi-Feed Stapler has application for use in a variety of minimally invasive procedures for approximation of tissue.
The Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler is a sterile, single patient use instrument designed for use with a 5mm diameter trocar. The device places rectangular titanium staples. The staple opens to a tip to tip width of about 6.1mm (0.240 inches). Closed staple dimensions are approximately 5.5 mm x 6.1 mm (0.215 inches x 0.242 inches). The instrument shaft is 5.5mm (0.218 inches) in diameter and 457mm (18 inches) long and contains about 40 staples.
The provided text describes a 510(k) premarket notification for a new surgical stapler. The submission focuses on demonstrating substantial equivalence to a predicate device through performance data, not on establishing acceptance criteria and conducting a study to prove a device meets those criteria in the context of AI/machine learning.
Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device submission.
Here's an analysis based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific quantitative acceptance criteria (e.g., specific staple strength, deployment accuracy rates) that the device must meet, nor does it present device performance data in a detailed, quantified table format suitable for head-to-head comparison against such criteria.
The "Performance Data" section generally states: "Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device performs as intended." This is a qualitative statement of intent and outcome, not a presentation of specific criteria and corresponding results.
2. Sample sized used for the test set and the data provenance
Not applicable. This is a traditional medical device submission primarily focused on mechanical performance and biocompatibility, not an AI/machine learning device submission involving test sets of data. The "bench testing and preclinical laboratory evaluations" likely involved a certain number of devices or staple deployments, but these numbers are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This concept of "experts establishing ground truth for a test set" is relevant to AI/ML where human expertise is used to label data. For a surgical stapler, "ground truth" would be established through engineering specifications, material science, and observed mechanical performance.
4. Adjudication method
Not applicable. Adjudication methods (like 2+1 or 3+1) are used in AI/ML studies to resolve discrepancies in expert labeling of data. This is not relevant to a surgical stapler's performance evaluation as described.
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. MRMC studies are used to evaluate the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the performance of an AI algorithm alone. The device is a surgical stapler, not an algorithm.
7. The type of ground truth used
For a surgical stapler, the "ground truth" would implicitly be defined by:
- Engineering Specifications: Designed dimensions, material properties, force requirements for staple formation and deployment.
- Biocompatibility Standards: Compliance with ISO 10993-1.
- Functional Performance Expectations: The ability to approximate tissue effectively, ensure proper staple formation, and preclude unintended failure modes.
- "Pathology" in the context of a stapler might relate to post-stapling tissue analysis, but not as the primary "ground truth" for proving the stapler itself works. "Outcomes data" would be from clinical use, not the bench and preclinical studies described here.
8. The sample size for the training set
Not applicable. This concept is for AI/ML models. The "design and development were predicated on use of technology currently used in Ethicon Endo-Surgery manual stapler devices," which could be considered analogous to a "training" history or experience base, but not a quantifiable data set in the AI sense.
9. How the ground truth for the training set was established
Not applicable. Similarly, the "ground truth" for the "training set" (if we consider previous stapler designs as training) would be established through the accumulated engineering knowledge, testing data, and clinical experience with those existing devices.
Summary based on the provided document:
The Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler's acceptance criteria and proof of meeting them are described in terms of a substantial equivalence pathway to a predicate device (Ethicon, Inc. ENDOPATH Disposable Endoscopic Multifeed (EMS) Stapler K913469).
The study that proves the device meets "acceptance criteria" (which are not explicitly detailed in the document as quantitative metrics but are implied by safe and effective surgical stapler performance) is the "Bench testing and preclinical laboratory evaluations". These evaluations were performed to demonstrate that the device performs as intended and that its new features "do not raise any new issues relating to safety and effectiveness" compared to the predicate device. Additionally, device materials were evaluated for biocompatibility and comply with the requirements of ISO 10993-1.
The document indicates that this data supports the conclusion that the new stapler is substantially equivalent to the predicate device. No specific quantitative performance metrics, sample sizes for detailed testing, or expert reviews for data labeling are provided in this summary.
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510(k) Summary
Company Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242
Contact
Renee Rowe Staff QS/RA Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road, ML 131 Cincinnati, OH 45242 Telephone: (513) 337-8243 Fax: (513) 337-2243 Email: rrowel@its.jnj.com
Date Prepared: September 10, 2010
New Device Name:
Trade Name: Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler Common or Usual Name: Surgical Stapler with Implantable Staples Classification Name: Implantable staple (21 CFR 878.4750, Product Code GDW Endoscope and Accessories, (21 CFR 876.1500, Product Code GCJ
Predicate Device:
Ethicon, Inc. ENDOPATH Disposable Endoscopic Multifeed (EMS) Stapler (K913469)
Device Description The Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler is a sterile, single patient use instrument designed for use with a 5mm diameter trocar. The device places rectangular titanium staples. The staple opens to a tip to tip width of about 6.1mm (0.240 inches). Closed staple dimensions are approximately 5.5 mm x 6.1 mm (0.215 inches x 0.242 inches). The instrument shaft is 5.5mm (0.218 inches) in diameter and 457mm (18 inches) long and contains about 40 staples.
Indications for Use The Ethicon Endo-Surgery® 5mm Laparoscopic Multi-feed Stapler has application for use in a variety of minimally invasive procedures for approximation of tissue.
Contraindications: This instrument is not intended for use in vascular or neural tissue or in solid organs such as liver or spleen. The staples in this instrument are not hemostatic and therefore should not be used to achieve hemostasis.
Technological Characteristics: Like the predicate, the ENDOPATH Disposable Endoscopic Multifeed (EMS) Stapler, the new Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler is a sterile single patient use instrument. The new device is designed for use in a 5mm diameter or larger port, while the EMS predicate is compatible with a 10/11mm port. Like the EMS predicate, the new device utilizes a titanium box staple and a pistol grip handle with a single trigger configuration. The
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staple of the EMS predicate device is formed and released with one activation of the trigger, while staples in the new device requires two activations - one to advance and open the staple, and a second to form the staple and release it. The shaft of the new device is 18 inches (457mm) long and contains about 40 staples, while the shaft of the predicate is 375mm long and contains 15-30 staples. The new and the predicate device both offer a 360° shaft rotation feature.
A comprehensive assessment of the Ethicon Endo-Surgery Smm Laparoscopic Multifeed Stapler versus the predicate device indicates the new features do not raise any new issues relating to safety and effectiveness.
Performance Data: Design and development were predicated on use of technology currently used in Ethicon Endo-Surgery manual stapler devices. Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device performs as intended. Device materials have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1. This data indicates the Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines extending from the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT =7 2010
Ethicon Endo-Surgery, Inc. % Ms. Renee Rowe Staff QS/RA Project Manager 4545 Creek Road Cincinnati, Ohio 45242
Re: K102632
Trade/Device Name: Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: September 10, 2010 Received: September 13, 2010
Dear Ms. Rowe:
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
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Page 2 - Ms. Renee Rowe
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,
for
Mark N. Melkerson
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
510(k) Number (if known): K102632
Ethicon Endo-Surgery® 5mm Laparoscopic Multi-feed Stapler Device Name:
Indications for Use:
The Ethicon Endo-Surgery® 5mm Laparoscopic Multi-Feed Stapler has application for use in a variety of minimally invasive procedures for approximation of tissue.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of
Page 1 of 1 (Posted November 13, 2003)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102632
15
§ 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.