(81 days)
The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of:
- Endoscopic marking, .
- Hemostasis for: ●
- o Mucosal and submucosal defects < 3 cm
- Bleeding ulcers o
- o Arteries < 2 mm
- o Polyps < 1.5 cm in diameter
- o Diverticula in the colon
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel, .
- Closure of GI tract luminal perforations < 20 mm in patients where an alternative . to surgery is required.
The InScope™ Mult-Clip Applier is a sterile, single patient use, disposable instrument capable of attaching clips to the mucosal lining of the gastrointestinal (GI) tract. The clips are used to create hemostasis and/or tissue approximation. The distal, flexible portion of the applier is designed to work with a flexible endoscope having a minimum working channel diameter of 3.2 mm. Two opposing jaws grasp tissue via a manually activated lever on a proximal handle. Once the closure lever is latched, a firing mechanism is manually activated, which deploys a titanium clip over the target tissue. The device is supplied preloaded with four (4) titanium clips.
The provided text describes the 510(k) summary for the InScope™ Multi-Clip Applier. This is a medical device submission, and the "study" referred to is the pre-clinical and bench testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical trial involving human subjects or AI algorithms. As such, many of the typical questions for AI/algorithm performance studies do not apply.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The "acceptance criteria" for this device are demonstrating substantial equivalence to predicate devices in specific performance aspects. The reported device performance is that it meets these criteria.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrate Substantial Equivalence in...) | Reported Device Performance |
|---|---|
| Hemostasis | Substantially equivalent |
| Clip retention | Substantially equivalent |
| Lack of tissue damage upon clip placement (tissue remains viable) | Substantially equivalent |
| Not likely to raise new or increased risks for specific indications (closure of GI perforations, fistulas, anastomotic leaks, control of bleeding diverticula) | Demonstrates safety and effectiveness comparable to similar marketed devices |
Study Details
-
Sample Size Used for the Test Set and Data Provenance:
- The document refers to "bench and preclinical testing" and "preclinical data." It does not specify sample sizes for these tests.
- Data provenance is preclinical/bench testing. No information on country of origin is provided, but typically, these tests are conducted by the manufacturer (Ethicon Endo-Surgery, Inc. in Cincinnati, OH, USA). The data is retrospective in the sense that it refers to testing done before the 510(k) submission.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This question is not applicable. The "ground truth" for a medical device like this is based on measurable physical properties and biological responses in preclinical models (e.g., tissue viability, clip retention force, hemostasis effectiveness), not on expert interpretations of medical images or patient outcomes in a clinical setting in the way an AI algorithm would be evaluated. These assessments are typically performed by engineers, biologists, or veterinarians specializing in device testing. The document does not specify the number or qualifications of these individuals.
-
Adjudication Method for the Test Set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies or to resolve discrepancies in expert labeling, which is not relevant here.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI algorithms that assist human readers in interpreting medical data (e.g., radiology images). The InScope Multi-Clip Applier is a physical surgical tool; its effectiveness is evaluated through direct performance metrics, not by how it influences human interpretation.
-
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The InScope Multi-Clip Applier is a physical device used by a clinician, not an algorithm. Its performance is inherently "with human-in-the-loop" as it requires manual operation.
-
The Type of Ground Truth Used:
- For the preclinical testing, the "ground truth" was based on direct measurements and observations of physical performance and biological responses in laboratory and animal models. This includes:
- Measured hemostatic effectiveness.
- Measured clip retention force/durability.
- Histopathological assessment of tissue viability after clip placement.
- Observation of outcomes for procedures like perforation closure in preclinical models.
- For the preclinical testing, the "ground truth" was based on direct measurements and observations of physical performance and biological responses in laboratory and animal models. This includes:
-
The Sample Size for the Training Set:
- Not applicable. This device does not use an AI algorithm that requires a training set. The "design and development" process would involve iterative testing and refinement, but this is distinct from machine learning training.
-
How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no AI algorithm or training set, this question does not apply.
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OCT 7 - 2005
InScope™ Multi-Clip Applier 510(k) Summary of Safety and Effectiveness
Company
INSCOPE A Division of Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact
Kimberly Shoemaker, RAC Manager, Regulatory Affairs
Date Prepared:
July 15, 2005
Name of Device
Trade Name: InScope™ Multi-Clip Applier Classification Name: Clip Applier/Endoscopic Clipping Device
Predicate Devices:
Trade Name: Syntheon, LLC: Endoscopic Multi-Fire Clip Applier Olympus Optical Co., Ltd .: Rotatable Clip Fixing Device HX-5/6-1
Device Description
The InScope™ Mult-Clip Applier is a sterile, single patient use, disposable instrument capable of attaching clips to the mucosal lining of the gastrointestinal (GI) tract. The clips are used to create hemostasis and/or tissue approximation. The distal, flexible portion of the applier is designed to work with a flexible endoscope having a minimum working channel diameter of 3.2 mm. Two opposing jaws grasp tissue via a manually activated lever on a proximal handle. Once the closure lever is latched, a firing mechanism is manually activated, which deploys a titanium clip over the target tissue. The device is supplied preloaded with four (4) titanium clips.
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pg 2 of 2
Indications for Use
The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of:
- Endoscopic marking, .
- Hemostasis for: ●
- o Mucosal and submucosal defects < 3 cm
- Bleeding ulcers o
- o Arteries < 2 mm
- o Polyps < 1.5 cm in diameter
- o Diverticula in the colon
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel, .
- Closure of GI tract luminal perforations < 20 mm in patients where an alternative . to surgery is required.
Technological Characteristics
The InScope™ Multi-Clip Applier does not have the identical indication statements as the predicate devices, but the differences noted do not alter the intended therapeutic/diagnostic effect.
Performance Data
Results of bench and preclinical testing demonstrate that performance of the InScope Multi-Fire Clip Applier is substantially equivalent to the predicate devices in regards to hemostasis, clip retention and lack of tissue damage upon clip placement (tissue remains viable).
A literature review in combination with the preclinical data demonstrates the use of the InScope Multi-Clip Applier for closure of gastrointestinal perforations, fistulas, anastomotic leaks and for control of bleeding diverticula is not likely to raise any new or increased risks to safety and effectiveness compared to risks experienced with similar marketed devices.
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Image /page/2/Picture/2 description: The image shows a logo with a stylized bird figure. The bird is composed of three curved lines that suggest movement or flight. To the left of the bird, there is text arranged in a circular fashion, oriented vertically. The text appears to be a company or organization name.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2005
Kimberly Shoemaker, RAC Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road CINCINNATI OH 45242-2839
Re: K051950
Trade/Device Name: InScope™ Multi-Clip Applier Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Product Codes: MND and FHN Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: KOG Regulatory Class: II Dated: September 23, 2005 Received: September 26, 2005
Dear Ms. Shoemaker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and bave 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 do not require approvisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your Apple 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 nanufacturing practice requirements as set forth in the quality systems (QS) (2) CFR Par 801 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a handwritten text string. The string appears to be a combination of letters and numbers. The text string reads 'K 05/1950'.
Indications for Use
510(k) Number (if known): 5051950 Device Name: InScope™ Multi-Clip Applier Indications for Use:
The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of:
- Endoscopic marking, .
- Hemostasis for: .
- Mucosal and submucosal defects < 3 cm O
- o Bleeding ulcers
- Arteries < 2 mm o
- Polyps < 1.5 cm in diameter o
- Diverticula in the colon ্ত
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel, ●
- Closure of GI tract luminal perforations < 20 mm in patients where an alternative . to surgery is required.
× Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart (21 CFR 801 Subpart C) D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Byrom
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_6,65195
Page 1 of 1
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.