Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)

K232826 · Steris · FBK · Mar 8, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K232826
• Device Name: Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
• Applicant: Steris
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Mar 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.

Device Story

Single-use, disposable, flexible sheath injection needles; used through working channel of flexible endoscopes. Device consists of handle luer, handle hypo tube, compression spring, PEEK tube, spring sheath, distal hub, and injection needle. User threads catheter through endoscope; upon reaching target site, user locks needle in deployed position by manipulating proximal/distal luer connection; needle inserted into GI mucosa; media administered via distal luer. Post-injection, needle retracted into sheath for removal. Used in clinical settings by physicians. Benefits include targeted delivery of therapeutic or diagnostic media to GI lesions.

Clinical Evidence

Bench testing only. No clinical data. Performance demonstrated via functional testing (tensile strength, deployment force, leakage, kink resistance) and simulated-use testing (endoscope compatibility, needle patency, penetration, and structural integrity in straight/articulated positions). All tests met design requirements.

Technological Characteristics

Materials: Polycarbonate luer, ABS plastic handle, 381G PEEK tube, 303/304 stainless steel components, PTFE coating, steel music wire spring. Principle: Mechanical luer-actuated needle deployment. Form factor: Flexible catheter with needle. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for use in patients requiring endoscopic injection of media into the gastrointestinal tract via flexible endoscopes.

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

• Sclerotherapy Needle (K212668)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

March 8, 2024

STERIS Carroll Martin Director, Regulatory Affairs 5976 Heislev Rd Mentor, Ohio 44060

## Re: K2328

Trade/Device Name: Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: February 5, 2024 Received: February 6, 2024

## Dear Carroll Martin:

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/cdrh/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

{1}------------------------------------------------

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).

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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

{2}------------------------------------------------

Sincerely,

# Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K232826

Device Name

| Articulator Injection Needle (00711807); |
|--------------------------------------------------------|
| Articulator Injection Needle (00711810); |
| Articulator Injection Needle - enteroscope (00711808); |
| Carr-Locke Injection Needle (00711811); |
| Carr-Locke Injection Needle (00711812); |
| Carr-Locke Injection Needle (00711813); |
| Carr-Locke Injection Needle (00711814); |
| Carr-Locke Injection Needle (00711822); |
| Carr-Locke Injection Needle (00711823); |
| Carr-Locke Injection Needle (00711824) |

Indications for Use (Describe)

These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.

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."

{4}------------------------------------------------

## 510(k) Summary For the Carr-Locke and Articulator Injection Needles K232826

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Contact: Carroll Martin Director, Regulatory Affairs

Telephone: [phone] Fax No: [phone] e-mail: [e-mail]

Summary Date: September 13, 2023

{5}------------------------------------------------

#### K232826 Page 2 of 6

#### Device Name Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Trade Name: Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) Device Class: Class II Endoscopic Injection Needles Common/usual Name: Endoscope and accessories Regulation Name: 21 CFR 876.1500 Regulation Number: FBK Product Code:

#### 2. Predicate Device

1.

Sclerotherapy Needle K212668

### Table 1. Device Comnarison Table for Carr-Locke and Articulator Needles and Predicate

| Feature | Sclerotherapy Needle<br>(Predicate Device/K212688) | Carr-Locke and Articulator<br>Needles<br>(Proposed Device) | Comparison |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The device is used for endoscopic<br>injection into gastrointestinal mucosa<br>or to endoscopically introduce a<br>sclerosing agent into selected sites to<br>control actual or potential bleeding<br>lesions in the digestive system | These single use, disposable, flexible<br>sheath injection needles are intended<br>to be used for the injection of various<br>types of media through flexible<br>endoscopes. | Similar. The<br>predicate device<br>mentions a sclerosing<br>agent, but this is a<br>type of media that is<br>injected into the<br>gastrointestinal tract,<br>which both devices<br>are intended to do. |
| Construction | Luer connector<br>Handle<br>Infusion tube<br>Sheath<br>Fixed button<br>Connection tube<br>Needle | Handle luer<br>Handle<br>Handle hypo tube<br>Compression spring (all needles<br>except P/N 00711808)<br>PEEK tube<br>Spring sheath<br>Distal hub<br>Injection needle | Similar. Although the<br>proposed devices<br>have a slightly<br>different design in<br>particular, the general<br>design of the devices,<br>a luer connection, a<br>handle, a sheath, a<br>tube through which<br>the media flows and a<br>needle are the same.<br>The slight differences<br>do not impact safety,<br>effectiveness or how<br>the device is used. |
| Sheath Diameter | 1.8mm and 2.4mm | 1.8mm and 2.5mm | Similar. The<br>differences in sheath<br>diameter between the<br>predicate and<br>proposed are minor.<br>This minor difference<br>does not impact |
| Feature | Sclerotherapy Needle<br>(Predicate Device/K212688) | Carr-Locke and Articulator<br>Needles | Comparison |
| | | (Proposed Device) | safety, effectiveness<br>or how the device is |
| | | | used. |
| Needle Size | 19 gauge<br>21 gauge<br>23 gauge<br>25 gauge | 23 gauge<br>25 gauge | Same |
| Working Length | 1200mm<br>1800mm<br>2000mm<br>2300mm | 2300mm<br>3500mm | Similar. The 3500mm<br>length of the<br>proposed device is to<br>allow the device to be<br>used in an<br>enteroscopy<br>endoscope. Testing<br>has shown that this<br>difference has not<br>impact on safety,<br>effectiveness or how<br>the device is used. |
| Packaging | Single-use EO sterilized paper-plastic<br>pouch with one device per pouch | Single-use EO sterilized Tyvek-<br>polyester/polyethylene film pouch.<br>All devices are packaged 5 devices to<br>a pouch except for P/Ns 00711810,<br>00711823 and 00711824 which are<br>packaged 10 to a pouch. | Similar. The<br>predicate and the<br>proposed devices are<br>packaged in sterilized<br>pouches. The larger<br>number of devices<br>packaged for the<br>proposed device does<br>not impact safety,<br>effectiveness or how<br>the devices are used. |
| Materials | Luer connector: ABS<br>Handle: ABS<br>Infusion tube: PP<br>Sheath: PTFE<br>Fixed button: Y12Cr18Ni9Cu3<br>Connection tube:<br>SUS304(06Cr19Ni10)<br>Needle:X5CrNi18-9 | Luer: polycarbonate<br>Male handle: ABS plastic with either<br>silver or white colorant<br>Female handle: ABS plastic with<br>either silver or white colorant<br>PEEK: 381G PEEK<br>Spring Sheath: 303 stainless steel<br>Spring Sheath coating (PNs<br>00711811,00711812,00711813,<br>00711814 and 00711822): PTFE<br>with green colorant<br>Handle hypo tube: 304 stainless steel<br>Distal hub: 303 stainless steel<br>Ferrule: 304 stainless steel<br>Compression spring: steel music wire | Similar. Both the<br>predicate and<br>proposed devices<br>contain stainless<br>steel, ABS plastic,<br>and PTFE. The main<br>difference is the<br>colorant present in<br>some of the proposed<br>devices, but testing<br>provided in this<br>submission show that<br>the colorant does not<br>impact safety,<br>effectiveness or how<br>the device is used. |
| Sterilization | Ethylene Oxide | Ethylene Oxide (SAL: 10-6) | Same |
| Method<br>Principle of<br>Operation | The catheter sheath of the<br>product is inserted into the<br>endoscope channel. When the front<br>part of the catheter sheath is placed | The user threads the catheter of the<br>device through the working channel<br>of the endoscope. Once the needle<br>has been threaded through the | Same |
| Feature | Sclerotherapy Needle<br>(Predicate Device/K212688) | Carr-Locke and Articulator<br>Needles<br>(Proposed Device) | Comparison |
| | on the lesion site, push the Luer<br>connector for injection, the needle is<br>exposed to the catheter sheath, and<br>the needle is inserted into the lesion<br>site, then drug injection. | endoscope and the injection site has<br>been reached, the user can lock the<br>needle into the deployed position by<br>pressing the proximal luer against<br>the distal luer and then turning the<br>proximal luer until it stops. The<br>needle can then be inserted into the<br>mucosa of the gastrointestinal tract.<br>Once the needle has been inserted,<br>the desired injection media can be<br>administered to the patient via the<br>distal luer connection. Once<br>injection is completed, the user can<br>retract the needle and remove the<br>device from the endoscope. | |

{6}------------------------------------------------

{7}------------------------------------------------

The proposed devices have the same intended use as the predicate with the same technological characteristics. Based on the testing in this submission, the minor physical differences do not impact safety, effectiveness or how the devices are used.

#### 3. Description of Device

The Carr-Locke and Articulator Injection Needles are single use, disposable, flexible sheath injection needles that are intended to be used for the injection of various types of media through flexible endoscopes. All the needles have the same general design and consist of a handle luer, a handle hypo tube, a compression spring (except for PN 00711808), a PEEK tube, a spring sheath, a distal hub and an injection needle.

The Carr-Locke and Articulator needles are sterile, disposable devices that are used through the working channel of flexible endoscopes for the purpose of injecting media into the gastrointestinal tract. Once the device is unpackaged from the sterile packaging, the user can purge the needle assembly of air by attaching the injection container (i.e. a syringe) to the proximal luer and dispensing 0.5 - 0.75 ccs of media. After purging the device, the user ensures the needle is fully retracted into the catheter of the device by slowly twisting the proximal luer until it disengages from the distal luer. Once verified that the needle has been fully retracted into the catheter, the user threads the catheter through the working channel of the endoscope. Once the needle has been threaded through the endoscope and the injection site has been reached, the user can lock the needle into the deployed position by pressing the proximal luer against the distal luer and then turning the proximal luer until it stops. The needle can then be inserted into the mucosa of the gastrointestinal tract. Once the needle has been inserted, the desired injection media can be administered to the patient via the distal luer connection. Once injection is completed, the user can retract the needle by disengaging the proximal and distal luers and allowing the compression spring to pull the needle into the sheath or by

{8}------------------------------------------------

physically grasping the proximal luer and pulling in the proximal direction until the needle enters the sheath (PN 00711808). Once the needle is retracted, the user can then remove the device from the endoscope.

#### 4. Intended Use/Indications for Use

These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.

#### ર. Summary of Nonclinical Tests

The Carr-Locke and Articulator Injection needles have a similar intended use and the same technological characteristics. The minor design differences and minor differences in intended use do not raise different questions of safety and effectiveness as compared to the predicate device. Testing to assess and demonstrate substantial equivalence to the predicate is summarized below:

| Functional Testing | | | |
|--------------------------------------------|--------------------------|---------|--|
| Testing | Acceptance Criteria | Results | |
| Working Length | Meet design requirements | Pass | |
| Needle Deployment Length | Meet design requirements | Pass | |
| Needle Handle Luer Compatibility | Meet design requirements | Pass | |
| Luer Compatibility | Meet design requirements | Pass | |
| Needle Deployment Length After Cycles | Meet design requirements | Pass | |
| Device Insertion Force | Meet design requirements | Pass | |
| Device Extraction Force | Meet design requirements | Pass | |
| Pentax Needle Scope Compatibility | Meet design requirements | Pass | |
| Device Catheter Kink Criteria | Meet design requirements | Pass | |
| Ferrule to Needle Tensile Force | Meet design requirements | Pass | |
| PEEK to Needle Tensile Force | Meet design requirements | Pass | |
| Handle Hypo Tube to PEEK Tensile Force | Meet design requirements | Pass | |
| Handle Hypo Tube to Luer Tensile Force | Meet design requirements | Pass | |
| Distal Hub to Spring Sheath Tensile Force | Meet design requirements | Pass | |
| Spring Sheath to Handle | Meet design requirements | Pass | |
| Handle Hypo Tube to Washer Tensile Force | Meet design requirements | Pass | |
| Male Handle to Female Handle Tensile Force | Meet design requirements | Pass | |
| Injection Force Gauge Comparison | Meet design requirements | Pass | |
| Needle Deployment Force & Retraction | Meet design requirements | Pass | |
| Needle Leakage Test | Meet design requirements | Pass | |

{9}------------------------------------------------

| Simulated Use Testing | | | |
|---------------------------------------------------------|--------------------------|--------|--|
| Testing | Acceptance Criteria | Result | |
| Endoscope Channel Compatibility | Meet design requirements | Pass | |
| Pentax Endoscope Compatibility | Meet design requirements | Pass | |
| Duodenoscope Compatibility | Meet design requirements | Pass | |
| Needle Deployment and Retraction | Meet design requirements | Pass | |
| Needle Deployment Lock | Meet design requirements | Pass | |
| Device Functions in a Straight and Articulated Position | Meet design requirements | Pass | |
| Needle Patency | Meet design requirements | Pass | |
| Duodenoscope Injection Compatibility | Meet design requirements | Pass | |
| Needle Penetration | Meet design requirements | Pass | |
| Leakage Requirement | Meet design requirements | Pass | |
| Device Maintains Structural Integrity | Meet design requirements | Pass | |

#### 6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device K212668, Class II (21 CFR 876.1500), product code FBK.