Who is the manufacturer of AMT Suture Passer?

Applied Medical Technology, Inc. filed the 510(k) submission for AMT Suture Passer (K241111).

What is the FDA product code for AMT Suture Passer?

GCJ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for AMT Suture Passer?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AMT Suture Passer?

Needle Point Suture Passer Instrument Set - CTSG; Carter-Thomason (K980123); ATLAS Suture Delivery System; Applied Medical Technology, Inc. (K193612); Cottony II Polyester Suture; Teleflex Medical (K192490); Cope Pediatric Gastrointestinal Suture Anchor Set & Enterostomy Suture Anchor Set; Cook Incorporated (K182832).

Who can help prepare an FDA 510(k) submission like AMT Suture Passer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AMT Suture Passer

K241111 · Applied Medical Technology, Inc. · GCJ · Jul 5, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K241111
Device Name	AMT Suture Passer
Applicant	Applied Medical Technology, Inc.
Product Code	GCJ · Gastroenterology, Urology
Decision Date	Jul 5, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.

Device Story

AMT Suture Passer is a sterile, single-use, hand-held device for passing and retrieving sutures through soft tissues. It features a hypodermic needle and is available in non-magnetic and magnetically assisted configurations. The magnetically assisted version uses a grasper with a magnetized arm to retrieve magnetic sutures, reducing technical difficulty during intracorporeal retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. The device includes a Luer-lock hub allowing syringe attachment for contrast administration to verify needle position during interventional radiology. Used by surgeons and interventional radiologists in clinical settings, the device provides flexibility in stitch geometry. It is manually operated without external power. The device benefits patients by facilitating secure suture placement in minimally invasive procedures.

Clinical Evidence

No clinical data or animal studies were performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993 series), sterilization validation (ISO 10993-7), shelf-life testing (ISO 11607, ISTA 3A), and mechanical performance testing (ISO 7864, ISO 9626, ISO 80369, and USP standards for tensile strength and needle attachment).

Technological Characteristics

Hand-held, manually operated, non-powered. Materials: 300-series stainless steel, Nitinol, thermoplastics, adhesives, and gold-plated neodymium magnets (in magnetic configuration). Features hypodermic needle (straight or curved) with echogenic treatment and Luer-lock hub. Sterilized via Ethylene Oxide (SAL 10^-6). Single-use. No electronic or software components.

Indications for Use

Indicated for passing suture through soft tissues during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent, and adult populations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Needle Point Suture Passer Instrument Set - CTSG; Carter-Thomason (K980123)
ATLAS Suture Delivery System; Applied Medical Technology, Inc. (K193612)
Cottony II Polyester Suture; Teleflex Medical (K192490)
Cope Pediatric Gastrointestinal Suture Anchor Set & Enterostomy Suture Anchor Set; Cook Incorporated (K182832)

Related Devices

K972911 — AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER · United States Surgical, A Division of Tyco Healthc · Apr 25, 1998
K022229 — SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 · Opus Medical, Inc. · Sep 6, 2002
K042031 — OPUS SPEEDSTITCH SUTURE DEVICE · Opus Medical, Inc. · Oct 19, 2004
K113763 — SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE · Nobles Medical Technologies Ii, Inc. · Mar 16, 2012
K123268 — SMARTSTITCH PERFECTPASSER SYSTEM · Arthocare Corporation · Nov 7, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the Department of Health & Human Services logo. July 5, 2024 Applied Medical Technology, Inc. Jennifer Hazou Regulatory Affairs Specialist 8006 Katherine Blvd. Brecksville, Ohio 44141 Re: K241111 Trade/Device Name: AMT Suture Passer Regulation Number: 21 CFR 21 CFR 876.1500 Regulation Name: Laparoscope, General & Plastic Surgery Regulatory Class: Class II Product Code: GCJ Dated: April 22, 2024 Received: April 22, 2024 Dear Jennifer Hazou: 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Long H. Chen Long H. Chen -S-S Date: 2024.07.05 10:56:26 -04'00' Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K241111 Device Name AMT Suture Passer Indications for Use (Describe) The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary AMT Suture Passer ### I. SUBMITTER: Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141 Phone: 440-717-4000 Fax: 440-717-4200 Contact Person: Jennifer Hazou - Regulatory Affairs Specialist Email: Jennifer.Hazou@appliedmedical.net Date Prepared: June 25, 2024 ## II. DEVICE INFORMATION: Trade/Device Name: AMT Suture Passer Common Name: Laparoscope, General & Plastic Surgery Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscope, General & Plastic Surgery Regulatory Class: II Product Code: GCJ #### III. PREDICATE INFORMATION: Carter-Thomason Predicate: K980123 (Needle Point Suture Passer Instrument Set - CTSG; Carter-Thomason) AMT Predicate Device: K193612 (Suture Delivery System; Applied Medical Technology, Inc.) Teleflex Predicate Device: K192490 (Cottony II Polyester Suture; Teleflex Medical) Cook Predicate Device: K182832 (Cope Pediatric Gastrointestinal Suture Anchor Set & Enterostomy Suture Anchor Set; Cook Incorporated) ** The predicate devices have not been subject to design-related recalls. ## IV. INDICATIONS FOR USE: The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations. #### DEVICE DESCRIPTION: V. The AMT Suture Passer is a sterile, single-case use, hand-held suture grasping device. The device features a hypodermic needle through which a suture can be passed and retrieved through another. The retrieval component may be offered in two configurations: a non-magnetic version, and a {4}------------------------------------------------ magnetically assisted version, using a grasper with a magnetized arm. Using either configuration, the AMT Suture Passer provides more flexibility in stitch geometry and approach than traditional Ustitches. The preferred method to introduce the suture is through a separate introducer needle; the AMT Suture Passer Kit with Magnet Assist instrument set bundles the magnetically assisted configuration of the AMT Suture Passer with an introducer needle and two magnetic sutures to create a non-procedure-specific kit. For the magnetically assisted configuration, the magnetized arm of the grasper works in conjunction with a magnetic suture to reduce the technical difficulty of intracorporeal suture retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. This magnet-assist technology is derived from the ATLAS Suture Delivery System (K193612), also manufactured by Applied Medical Technology, which performs the same clinical function and is used in similar clinical applications. Both configurations of the AMT Suture Passer feature identical components, except for the endeffectors, and make use of Luer-lock compatible hubs that allow a syringe to be attached for the purpose of administering contrast through the device. The contrast enters through the Luer hub and exits from the distal end of the needle, which allows the needle position to be verified prior to passing the suture during interventional radiology procedures. {5}------------------------------------------------ ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATES: | | | Subject | Carter-Thomason Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | AMT Suture Passer (KXXXXXX) | Carter-Thomason SG Suture Passer (K980123) | ATLAS Suture Delivery System (K193612) | Cottony II Suture (K153076, K021019, K192490) | Cope Enterostomy Suture Anchor Set and Cope Pediatric Gastrointestinal Suture Anchor Set (K182832) | Comparison | | Classification | Device Classification | Class II | Class II | Class II | Class II | Class II | SAME AS PREDICATE | | | Product Codes | GCJ | GCJ | KGC | GAT | KGC | The subject device has the same classification and product code as the predicate. | | | Regulation No. | 876.1500 | 876.1500 | 876.5980 | 878.5000 | 876.5980 | | | | Panel | General & Plastic Surgery | General & Plastic Surgery | Gastroenterology/ Urology | General & Plastic Surgery | Gastroenterology/ Urology | | | Sterility | Condition | Provided sterile | Provided sterile | Provided sterile | Provided sterile | Provided sterile | SAME AS PREDICATE | | | Reprocessing | Single use only; not re- processable | Single use only; not re- processable | Single use only; not re- processable | Single use only; not re- processable | Single use only; not re- processable | The subject device and predicate devices are sterile, single-use devices that are not re-processable. Sterilization method (EO) is the same and similar packaging is employed, including a tray for organization, and a peel-open Tyvek lid to maintain the sterile barrier. The subject device also uses a pouch, which provides a second sterile barrier. | | | Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | | | Packaging | Tray w/peel-open Tyvek lid inside peel- open Tyvek pouch | Tray w/ peel-open Tyvek lid | Tray w/peel-open Tyvek lid inside peel- open Tyvek pouch | Peel-open paper packet inside peel-open Tyvek pouch | Peel-open Tyvek Pouch | | | | Assurance Level | SAL 10-6 | SAL 10-6 | SAL 10-6 | SAL 10-6 | SAL 10-6 | | | | | Subject | Carter-Thomason Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | Comparison | | | | AMT Suture Passer (KXXXXXX) | Carter-Thomason SG Suture Passer (K980123) | ATLAS Suture Delivery System (K193612) | Cottony II Suture (K153076, K021019, K192490) | Cope Enterostomy Suture Anchor Set and Cope Pediatric Gastrointestinal Suture Anchor Set (K182832) | | | | Prescription | Prescription Only | Prescription Only | Prescription Only | Prescription Only | Prescription Only | SAME AS PREDICATE | | User Population | Intended User | Surgeons trained in endoscopic, and/or laparoscopic techniques and/or interventional radiologists. | Surgeons trained in endoscopic and/or laparoscopic techniques | Surgeons trained in endoscopic techniques | Various clinicians trained in the use of sutures | Surgeons, gastrointestinal doctors, and interventional radiologists | The subject device and the predicate devices are prescription only devices that serve the same user populations. | | Clinical Application | Indications for Use | Indicated to pass suture through soft tissues of the body during endoscopic/laparoscopi c surgery and interventional radiology procedures in child, adolescent and adult populations. | Indicated to pass suture through soft tissues of the body during endoscopic/ laparoscopic surgery | Intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days, in child, adolescent, and adult populations | Indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic and neurological procedures | Intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days | SIMILAR TO PREDICATE The subject device differs from the predicate in the addition of interventional radiology procedures to the indications for use, and in the inclusion of the patient population in the indications for use. | | | Intended Use | Passes a suture through soft tissues of the body | Passes a suture through soft tissues of the body | Passes a suture through soft tissues of the body for the purpose of securing a hollow viscus to the anterior abdominal wall | Approximation and/or ligation of soft tissues | Delivers a suture with a metal anchor through soft tissues of the body for the purpose of securing the stomach to anterior the abdominal wall | Expansion of the indication to IR procedures is supported because the subject device allows contrast to be injected through the device. | | | | Subject | Carter-Thomason Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | | | | | AMT Suture Passer (KXXXXXX) | Carter-Thomason SG Suture Passer (K980123) | ATLAS Suture Delivery System (K193612) | Cottony II Suture (K153076, K021019, K192490) | Cope Enterostomy Suture Anchor Set and Cope Pediatric Gastrointestinal Suture Anchor Set (K182832) | Comparison | | | Procedural Use | General surgery | General surgery | Pexy procedures (e.g., gastropexy, jejunopexy, cystopexy, etc.) | General surgery (including cardiovascular, ophthalmic, orthopedic and neurological procedures) | Gastropexy | The addition of the patient population to the indications is keeping in line with current best practices for device labeling. | | | Device | Not MR-safe | Not MR-safe | Not MR-safe | N/A - SUTURE ONLY | Not MR-safe | SAME AS PREDICATE | | MR Safety | Suture | For the configuration which features magnetically assisted end-effectors, suture is MR-safe after magnet head is removed | *Suture not included, but required in accordance with labeling. Suture is MR- safe after needle is removed. | Suture is MR-safe after magnet head is removed | Suture is MR-safe after needle is removed | Suture is MR- conditional due to metal T-bar anchor that remains inside the patient after placement | Neither the subject device nor the predicate devices are MR- safe. Suture placed using any of the devices is MR-safe when placed in accordance with the labeling. | | Configurations | Instrument Kit(s) | For the configuration which features magnetically assisted end-effectors, YES - AMT Suture Passer Kit | For the configuration that features port closure elements, YES - Carter-Thomason II Port Closure System | NO | NO | YES - Gastropexy Kit | SIMILAR TO PREDICATE The subject device uses a small gauge needle that is shorter than the predicate and may be offered in curved configurations. | | | Needle Sizes | 17-gauge: May be offered curved or straight, depending on configuration. | 14-gauge | 17-gauge | Multiple sizes: Needle size scales with suture size | 18-gauge | The subject device utilizes an echogenic treatment on the needle. | | Technological Characteristics | | Subject | Carter-Thomason Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | | | | | AMT Suture Passer (KXXXXXX) | Carter-Thomason SG Suture Passer (K980123) | ATLAS Suture Delivery System (K193612) | Cottony II Suture (K153076, K021019, K192490) | Cope Enterostomy Suture Anchor Set and Cope Pediatric Gastrointestinal Suture Anchor Set (K182832) | Comparison | | | Needle Length | 2.5 in. [6.35 cm] | 8.3 in. [120.82 cm] | 2.5 in. [6.35 cm] | Multiple sizes available (needle size scales relative to suture size) | 7 cm | Suture is included with one configuration of the subject device, but must be furnished by the user with the other and the predicate. | | | Needle Type | Hypodermic (hollow, round cross-section) | Hypodermic (hollow, round cross-section) | Hypodermic (hollow, round cross-section) | Solid, available in multiple cross-sectional shapes | Hypodermic (hollow, round cross-section) | the predicate. | | | Needle Finish | As-drawn; echogenic treatment | As-drawn | As-drawn | Machined/ground | As-drawn | | | | Suture Size | For the configuration which features magnetically assisted end-effectors, USP 3-0 | *Suture not included. Recommended size is USP 1 | USP 3-0…