(211 days)
Not Found
No
The device description focuses on mechanical components and procedures for tissue apposition using sutures and anchors. There is no mention of AI, ML, image processing, or any computational analysis of data for decision-making or control.
Yes
The device is used to approximate soft tissue and treat defects like ulcers and perforations, which are therapeutic actions.
No
The device is indicated for endoscopic placement of sutures and approximation of soft tissue to treat defects like ulcers and perforations; it does not diagnose conditions.
No
The device description clearly outlines multiple physical components including a Tissue Anchor Applier, Tissue Anchor with suture, Knotting Element Applier, and Knotting Element, all of which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic placement of suture(s) and approximation of soft tissue" within the gastrointestinal tract. This is a surgical/therapeutic procedure performed in vivo (within the living body).
- Device Description: The description details a system for placing sutures and securing tissue within the body using an endoscope. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic purposes. This device is used to perform a physical intervention on tissue within the body.
N/A
Intended Use / Indications for Use
The Tissue Apposition System (TAS) is indicated for endoscopic placement of suture(s) and approximation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
OCW, MXW, GAW
Device Description
The InScope™ Tissue Apposition System is a sterile, single patient use disposable suture system for approximating and securing soft tissue within the gastrointestinal tract. It is intended to perform suturing in conjunction with endoscopes having a working channel of 2.8 mm or larger.
There are four essential devices, and two secondary components:
- Tissue Anchor Applier
- Tissue Anchor with suture
a. Tissue Anchor Loader - Knotting Element Applier
- Knotting Element
a. Knotting Element Loader
The InScope™ Tissue Anchor Applier is used to place and anchor sutures in the tissue of the GI tract. Suture position is maintained via a metal tissue anchor structure attached to the distal end of each suture strand. Following suture placement, the Knotting Element Applier is advanced over the trailing ends of the anchored sutures and advanced distally. After the sutures are properly tensioned to appose tissue, the Knotting Element is deployed to secure the suture and cut the trailing ends. The Tissue Apposition System can be used to treat a variety of defects endoscopically, including ulcers and perforations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract, GI tract, colonic, gastric
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and animal testing was performed to demonstrate the new device performs as intended. Bench testing demonstrated the holding strength of the InScope™ Knotting Element component is substantially equivalent to the Bard® EndoCinch™ suture anchor, and that the anchor attachment force meets the USP requirement. Testing in the porcine animal model demonstrated successful closure of colonic and gastric perforations, with normal results for the healing process.
Each material in the InScope™ Tissue Apposition System was assessed for biocompatibility using ISO 10993-1: "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" and FDA General Program Memorandum #G95-1 : Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing." and each was found to be biocompatible. Biocompatibility for both limited patient contacting and permanent patient contacting/implant materials has been established through history of use in other marketed Ethicon Endo-Surgery medical devices and biocompatibility test results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K003956, K011016, K061770, K062875
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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K070151
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510(k) Summary
AUG 15 2007 Ethicon Endo-Surgery, LLC Company 475 Calle C Guaynabo, Puerto Rico 00969 Contact Kimberly Shoemaker, RAC Group Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-8123 Fax: (513) 337-2123 Email: kshoemal@eesus.jnj.com Date Prepared January 15, 2007 Device Name Trade Name: InScope™ Tissue Apposition System Common or Usual Name: Tissue Apposition System Classification Name: Endoscope and Accessories[21CFR 876.1500 (OCW, MXW, GAW)] Bard® EndoCinch™ Suturing System (K003956) Predicate Device LSI Solutions Flexible Suture Placement Device and Acc (K011016) Ethicon Endo-Surgery" Endoscopic Suturing System (K061770)
EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system (K062875)
Device Description
The InScope™ Tissue Apposition System is a sterile, single patient use disposable suture system for approximating and securing soft tissue within the gastrointestinal tract. It is intended to perform suturing in conjunction with endoscopes having a working channel of 2.8 mm or larger.
There are four essential devices, and two secondary components:
- Tissue Anchor Applier 1.
-
- Tissue Anchor with suture a. Tissue Anchor Loader
- Knotting Element Applier 3.
-
- Knotting Element
- a. Knotting Element Loader
1
The InScope™ Tissue Anchor Applier is used to place and anchor sutures in the tissue of the GI tract. Suture position is maintained via a metal tissue anchor structure attached to the distal end of each suture strand. Following suture placement, the Knotting Element Applier is advanced over the trailing ends of the anchored sutures and advanced distally. After the sutures are properly tensioned to appose tissue, the Knotting Element is deployed to secure the suture and cut the trailing ends. The Tissue Apposition System can be used to treat a variety of defects endoscopically, including ulcers and perforations.
Indications for Use The InScope™ Tissue Apposition System is indicated for endoscopic placement of suture(s) and approximation of soft tissue.
Technological Characteristics The InScope™ Tissue Apposition System is similar in design to the Bard® EndoCinch™ and Ethicon Endo-Surgery® Endoscopic Suturing System predicate devices, as both devices provide an endoscopic means of suture termination. The new device is different from these predicates devices as it does not attach externally to an endoscope, but is advanced down the working channel of the endoscope.
Performance Data Bench and animal testing was performed to demonstrate the new device performs as intended. Bench testing demonstrated the holding strength of the InScope™ Knotting Element component is substantially equivalent to the Bard® EndoCinch™ suture anchor, and that the anchor attachment force meets the USP requirement. Testing in the porcine animal model demonstrated successful closure of colonic and gastric perforations, with normal results for the healing process.
Each material in the InScope™ Tissue Apposition System was assessed for biocompatibility using ISO 10993-1: "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" and FDA General Program Memorandum #G95-1 : Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing." and each was found to be biocompatible. Biocompatibility for both limited patient contacting and permanent patient contacting/implant materials has been established through history of use in other marketed Ethicon Endo-Surgery medical devices and biocompatibility test results.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15 2007
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Ms. Kimberly Shoemaker, RAC Group Manager, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242
Re: K070151
Trade/Device Name: InScope™ Tissue Apposition System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW, MXW, GAW Dated: July 10, 2007 Received: July 11, 2007
Dear Ms. Shoemaker:
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.
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 - Ms. Kimberly Shoemaker, RAC
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Your 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 yours,
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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K070151
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Indications for Use
510(k) Number (if known): __K070151
Device Name: InScope™ Tissue Apposition System
Indications for Use:
The Tissue Apposition System (TAS) is indicated for endoscopic placement of suture(s) and approximation of soft 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 Device Evaluation (ODE) Page 1 of 1 (Posted November 13, 2003)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number