LiNA OperaScope Needle

K221085 · Lina Medical Aps · FBK · Sep 2, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K221085
• Device Name: LiNA OperaScope Needle
• Applicant: Lina Medical Aps
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Sep 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.

Device Story

The LiNA OperaScope™ Needle is a sterile, single-use endoscopic injection needle designed for use with the LiNA OperaScope. The device features a handle, a shaft, and a 23G needle with a 3-bevel tip. It is advanced to the bladder via the urethra or to the uterus via the cervix through the working channel of an endoscope. A luer-lock connection at the proximal end allows for the attachment of a syringe to deliver injectable materials into tissue. Used in hospitals and physician offices by gynecologists and urologists, the device facilitates targeted tissue injections. The needle's design, including its 4mm or 8mm length and 313mm working length, is optimized for the LiNA OperaScope's technical requirements. By enabling precise delivery of therapeutic agents, the device assists clinicians in performing diagnostic or therapeutic hysteroscopic and cystoscopic procedures.

Clinical Evidence

No clinical data. The device's safety and effectiveness were demonstrated through non-clinical performance testing, including functional bench testing (insertion/retraction forces, rotation, distention fluid clearance, and geometric dimensions) and biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogen, and hemocompatibility) in accordance with ISO 10993 and ASTM standards.

Technological Characteristics

Single-use endoscopic injection needle; 23G needle width; 4mm or 8mm needle length; 313mm working length; 3-bevel tip; luer-lock connection; EtO sterilization; biocompatible materials per ISO 10993; shelf life of 36 months; designed for use with LiNA OperaScope (minimum channel diameter 2.0mm/5 Fr).

Indications for Use

Indicated for hysteroscopic injection into the uterine wall and cystoscopic injection into the urinary bladder wall in patients undergoing these procedures. Intended for use by trained medical professionals, specifically gynecologists and urologists.

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

• Cook Injection Needles (K022484)

Submission Summary (Full Text)

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September 2, 2022

LiNA Medical ApS % Scott Blood Director of Regulatory Services MEDIcept, Inc. 200 Homer Avenue Ashland, MA 01821

Re: K221085

Trade/Device Name: LiNA OperaScope™ Needle Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK, HIH Dated: July 29, 2022 Received: August 4, 2022

Dear Scott Blood:

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. 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 located 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 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.

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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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K221085

Device Name LiNA OperaScope™ Needle

Indications for Use (Describe)

LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as for cystoscopic injection in the urinary bladder wall.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------------|
| <label> <input type="checkbox"/> Transactional Use (Limited to SEC Rule 144A and/or Regulation S) </label> |
| <label> <input type="checkbox"/> Other - Direct placement with accredited investors </label> |

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary LiNA OperaScope™ Needle K221085

#### 1. Submission Sponsor

LiNA Medical ApS Formervangen 5 DK-2600 Glostrup, Denmark Contact: Jarosław Mrówczyński Title: Regulatory Affairs Manager Email: [e-mail] Office number: [phone]

## 2. Submission Correspondent

Scott Blood Director of Regulatory Services MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 Email: [e-mail] Office number: [phone]

#### 3. Date Prepared

September 1, 2022

#### 4. Device Identification

| Trade/Proprietary Name: | LiNA OperaScope™ Needle |
|-------------------------|---------------------------|
| Common/Usual Name: | Needle |
| Classification Name: | Endoscope and Accessories |
| Regulation Number: | 876.1500 |
| Primary Product Code: | FBK |
| Reference Product Code: | HIH |
| Device Class: | Class II |
| Classification Panel: | Gastroenterology/Urology |

## 5. Legally Marketed Predicate Device(s)

Through FDA database search following predicate device has been identified: Cook Injection Needles manufactured by Cook Urological, Inc (K022484). No design-related recalls for these legally marketed predicate devices have been identified.

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#### 6. Indication for Use Statement

LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.

#### 7. Device Description

LiNA OperaScope™ Needle is delivered as a sterile, single-use device designed to be used specifically with the LiNA OperaScope for hysteroscopic and cystoscopic injections. The device consists of a handle, a shaft and an injection needle, which is pointed at the distal end and has a luer-lock connection at the proximal end. Devices are packed in Tyvek pouches, with 6 units packed in a box. Model numbers are presented in Table 1.

| Reference number | Description |
|------------------|------------------------------------------------------------------|
| OP-NEE4-6 | LiNA OperaScope™ Needle 4mm, minimum channel<br>diameter: Ø2.0mm |
| OP-NEE8-6 | LiNA OperaScope™ Needle 8mm, minimum channel<br>diameter: Ø2.0mm |

#### 8. Substantial Equivalence Discussion

Cook Injection Needle (K022484)

The LiNA OperaScope Needle is similar to the Cook Injection Needle in terms of indications for use and technological characteristics (required inner channel diameter, needle length, tip shape and presence of Luer lock).

Table 2 compares the LiNA OperaScope Needle to the predicate device with respect to the indications for use, principles of operation, materials, dimensions and operational mode. The predicate specifies needles are only intended to be used with rigid endoscopes.

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| Manufacturer | LiNA Medical ApS | Cook Urological | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Trade Name | LiNA OperaScope™ Needle<br>(K221085) | Cook Injection Needles<br>(K022484) | |
| Common Name | Endoscopic Injection Needle, Gastroenterology-urology; | Endoscopic Injection Needle, Gastroenterology-urology | |
| Primary Product<br>Code | FBK | FBK | |
| Regulation<br>Number | 876.1500 | 876.1500 | |
| Regulation Name | Endoscope and Accessories; | Endoscope and Accessories | |
| Indications for<br>Use | LiNA OperaScope™ Needle is intended for hysteroscopic injection into the<br>uterine wall as well as for cystoscopic injection in the urinary bladder<br>wall. | The Cook Injection Needles are used to deliver a variety of injectable<br>materials into tissues during laparoscopic, hysteroscopic, cystoscopic,<br>endoscopic transurethral procedures and open surgical procedures. The<br>type of material to be injected will be dependent on the nature of the<br>procedure. The needle is intended to be used with legally marketed drugs<br>and devices. | |
| Intended Users | Trained Medical Professionals – Gynecologists and Urologists | Trained Medical Professionals - Gynecologists and Urologists | |
| Site of Use | Hospital and Physician Offices | Hospital and Physician Offices | |
| Route of<br>advancement | Advanced to the bladder via the urethra and to the uterus via the cervix<br>through the working channel of the endoscope. | Advanced to the bladder via the urethra and to the uterus via the cervix<br>through the working channel of the endoscope. | |
| Required channel<br>inner diameter | 5 Fr | 3.7 to 9 Fr | |
| Needle length | 4 or 8 mm | Unknown | |
| Needle width | 23G | 16-25G | |
| Working length | 313 mm | 150 - 650 mm | |
| Tip shape | 3-bevel tip | 3-bevel tip | |
| Sterilization<br>method | EtO | EtO | |
| Duration of use | ≤ 24 hours | ≤ 24 hours | |
| Frequency of use | Single use | Single use | |
| Components | Injection Needle with Luer lock fitting to the syringe and protection cap<br>for the tip | Injection Needle with Luer lock fit to the syringe | |
| Patient<br>Contacting<br>Materials | The LiNA OperaScope Needle is tested according to ISO 10993 to assure<br>that patient contacting materials are biocompatible. | Compliant with ISO 10993 | |

| | | | | Table 2 - Comparison LiNA OperaScope Needle and predicate device |
|--|--|--|--|------------------------------------------------------------------|
|--|--|--|--|------------------------------------------------------------------|

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| Manufacturer | LiNA Medical ApS | Cook Urological |
|--------------|-----------------------------------------------------------|-------------------------------------|
| Trade Name | LiNA OperaScope™ Needle<br>(K221085) | Cook Injection Needles<br>(K022484) |
| Packaging | Tyvek pouch for single device,<br>6 devices packed in box | Tyvek-Poly Pouch |
| Shelf Life | 36 months | 36 months |

LiNA OperaScope™ Needle is designed specifically for LiNA OperaScope and adjusted to the technical requirements of this device.

The LiNA OperaScope Needle has the similar indications for use and technological characteristics as compared to the differences in indications for use do not constitute a new intended use. Additionally, there are no different questions of safety and effectiveness that arise from the differences in technological differences between LiNA OperaScope Needle and the predicate device can be evaluated through performance testing and do not alter the intended use of the LiNA OperaScope Needle.

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#### 9. Non-Clinical Performance Data

In an effort to demonstrate safety and effectiveness of the LiNA OperaScope Needle and to support equivalence to the predicate devices that are subject to this 510(k) submission, LiNA completed a number of non-clinical performance tests. The LiNA OperaScope Needle met all the requirements for overall design, sterilization and biocompatibility results confirming that the design output meets the design inputs and specifications for the device.

#### Functional Testing:

Functional bench testing was performed to demonstrate the adequate functionality of the LiNA OperaScope Needle, as follows:

- Insertion in Tissue <5N
- Exposure and retraction force <15N
- Detachable limit buckle present
- 360° rotation in LiNA OperaScope
- Distention fluid clearance
- Blockage of OperaScope camera
- Inability to pass needle with protective cap through OperaScope working channel
- The insertion and extraction force to/from OperaScope working channel <10N
- Visual Inspection
- Device Geometric Dimensions
- Device weight
- . Device Surface
- . Device robustness
- Biological Risk Assessment
- Bioburden Evaluation
- Endotoxin/LAL Evaluation
- Distention fluid clearance

The studies confirm that it is possible to insert the device into tissue of the uterine cavity, female urethra, and uterine bladder and function as described in the intended use.

#### Biocompatibility:

Biocompatibility studies were performed in accordance with the 2020 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evlauation and "testing" as follows:

- . Cytotoxicity: ISO 10993-5:2009
- Irritation: ISO 10993-10:2010
- Sensitization: ISO 10993-10:2010
- . Acute Systemic Toxicity: ISO 10993-11:2017
- Material-mediated pyrogen: USP <151>, ISO 10993-11:2017
- Hemocompatibility: ASTM F756-17 ●

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#### Shelf-Life:

The LiNA OperaScope Needle has a shelf life of 3 years when packaged in Tyvek pouches, in accordance with the results of accelerated aged stability studies. Results from testing demonstrated that the devices could maintain their specifications over the stated shelf-life duration.

#### 10. Clinical Performance Data

Not applicable for LiNA OperaScope Needle.

#### 11. Statement of Substantial Equivalence

The LiNA OperaScope™ Needle has the same intended use as the predicate device. The LiNA OperaScope™ Needle has different technological characteristics from the predicate device, but these differences do not raise different questions of safety and effectiveness. Performance testing, as described above, demonstrates that the LiNA OperaScope™ Needle is as safe and effective as the predicate. Therefore, the LiNA OperaScope™ Needle is substantially equivalent to the referenced predicate device.