(7 days)
The Modified Endo Stitch™ 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues
The Modified Endo Stitch™ is an endoscopic suturing device that contains two jaws at its distal end, with opposing handles and a toggle lever at its proximal end.
The provided text describes a 510(k) premarket notification for a medical device called the "Modified Endo Stitch™ Endoscopic Suturing Device." However, the document does NOT contain explicit acceptance criteria, detailed study designs, or specific performance metrics that would typically be found in a clinical study report.
The information primarily focuses on the device description, intended use, materials, and a general statement about performance data.
Therefore, many of the requested details cannot be extracted from the provided text. Below is an attempt to answer the questions based on the available information and to indicate where the information is not present.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific acceptance criteria and detailed quantitative performance metrics are not explicitly stated. The document only broadly mentions:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated) | In-vitro and in-vivo testing has been performed in support of the intended use of this device. (Page 21, {1}) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "In-vitro and in-vivo testing has been performed" but does not specify sample sizes, origin of data, or study design (retrospective/prospective).
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)
This information is not provided in the document. Such details would typically be part of a detailed study report, which is not present here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This device is an endoscopic surgical suturing device, not an AI-powered diagnostic or imaging interpretation tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance is not relevant to this type of device and is not described in the provided text.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a manual surgical tool and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document only states that "In-vitro and in-vivo testing has been performed in support of the intended use of this device." (Page 21, {1}). It does not specify the type of ground truth used for these tests. In the context of a surgical device, "ground truth" would likely relate to the successful and safe performance of the suturing function, potentially evaluated through physical-mechanical testing (in-vitro) and animal or human studies (in-vivo) assessing factors like suture strength, tissue closure, and absence of complications, but these specifics are not elaborated.
8. The sample size for the training set
This information is not provided in the document. The concept of a "training set" is usually associated with machine learning or AI models, which is not the nature of this device.
9. How the ground truth for the training set was established
This question is not applicable as the device is a manual surgical tool and not an AI-powered system that requires a "training set" with established ground truth in the typical sense.
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| Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) | ||
|---|---|---|
| 5. 510(K) SUMMARY: | K082659nag | |
| 510(k) Summary of Safety and Effectiveness: | SEP 1 9 2008 | |
| SUBMITTER: | Surgical Devices, a global business unit of TycoHealthcare Group LP (d/b/a Covidien)60 Middletown AvenueNorth Haven, CT 06473 | |
| CONTACT PERSON: | Robert ZottProgram Director, Regulatory AffairsPhone: (203) 492-6013Fax: (203) 492-5029 | |
| DATE PREPARED: | September 11, 2008 | |
| TRADE/PROPRIETARY NAME: | Modified Endo Stitch™ | |
| COMMON/USUAL NAME: | Endoscopic Suturing Device | |
| CLASSIFICATION NAME: | Endoscope and accessories | |
| PREDICATE DEVICE(S): | K934738: Autosuture™ Endoscopic SuturingDevice | |
| DEVICE DESCRIPTION: | The Modified Endo Stitch™ is an endoscopicsuturing device that contains two jaws at itsdistal end, with opposing handles and a togglelever at its proximal end. |
INTENDED USE:
TECHNOLOGICAL CHARACTERISTICS:
The device holds and passes a needled suture between the two jaws. The suture needle is passed from one jaw to another by squeezing the
opposing handles and secured in each jaw by
:
activating the toggle lever.
For use in endoscopic surgery for the placement
of interrupted or running stitches in soft tissues
- Trademark of Tyco Healthcare Group I.P d/b/a Covidien September 11, 2008
Special 510(k) for the Modified Endo Stitch™ Endoscopic Suturing Device
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K082659 pag
MATERIALS:
All patient contact materials in the Modified Endo Stitch™ have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices --Part 1: Evaluation and Testing.
PERFORMANCE DATA:
In-vitro and in-vivo testing has been performed in support of the intended use of this device.
- Trademark of Tyco Healthcare Group LP d/b/a Covidien September 11, 2008
Special 510(k) for the Modified Endo Stitch™M Endoscopic Suturing Device
Page 21
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Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.
SEP 1 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Covidien % Mr. Robert Zott Program Director, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K082659
Trade/Device Name: Modified Endo Stitch™ - Trade name to be determined Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated: September 11, 2008 Received: September 12, 2008
Dear Mr. Zott:
We have reviewed your Scction 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Robert Zott
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT:
510(k) Number (if known):
Device Name:
Modified Endo Stitch™ - Trade name to be determined.
Indications For Use:
The Modified Endo Stitch™ 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues
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)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, | |
| and Neurological Devices |
| 510(k) Number | L082659 |
|---|---|
| --------------- | --------- |
| * Trademark of Tyco Healthcare Group LP d/b/a Covidien September 11, 2008 | Special 510(k) for the Modified Endo Stitch™ Endoscopic Suturing Device |
|---|---|
| --------------------------------------------------------------------------- | ------------------------------------------------------------------------- |
Page 19
§ 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.