Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile

K191715 · STERIS Corporation · OCU · Jan 27, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K191715
• Device Name: Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile
• Applicant: STERIS Corporation
• Product Code: OCU · Gastroenterology, Urology
• Decision Date: Jan 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the purpose of protecting the endoscope's delicate lens and the endoscope's bending rubber during transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.

Device Story

Single-use molded plastic protective cover; open cage-like configuration; fits endoscopes/instruments with 4.9mm-15mm outer diameter. Protects distal tips, lenses, and bending mechanisms during transport and storage. Used in clinical settings; applied by healthcare staff. Internal diaphragm with minimal contact points secures device to instrument. Provides impact protection; remains attached for at least 7 days. Available in sterile and non-sterile versions.

Clinical Evidence

Bench testing only. Verification activities included attachment/detachment force, impact force reduction, transport retention, 7-day longevity of hold, ISO 10993-10:2010 irritation/sensitization, ISO 10993-5:2009 cytotoxicity, and sterile packaging validation per ASTM F88/F88M-15, ASTM F2096-11, and ASTM F1886/F1886M-16.

Technological Characteristics

Non-porous plastic; open cage-like design; 10.2 cm length; fits 4.9mm-15mm OD. Biocompatible per ISO 10993. Sterile and non-sterile options. Packaging: Tyvek pouch (sterile) or poly bag (non-sterile).

Indications for Use

Indicated for protection of distal tips of endoscopes and medical/surgical instruments, specifically delicate lenses and bending rubbers, during transport and storage.

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

• Endo-boot - endoscope tip protector (K951104)

Submission Summary (Full Text)

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January 27, 2020

STERIS Corporation Jennifer Nalepka Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, OH 44060

Re: K191715

Trade/Device Name: Endoscope Tip Protector - Sterile Endoscope Tip Protector - Non-sterile Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OCU Dated: January 9, 2020 Received: January 10, 2020

Dear Jennifer Nalepka:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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).

Sincerely,

Shanil P. Haugen, Ph.D. Acting 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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K191715

### Device Name

Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile

### Indications for Use (Describe)

The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the endoscope's delicate lens and the endoscope's bending transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.

Type of Use (Select one or both, as applicable)

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

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

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Image /page/3/Picture/1 description: The image shows the logo for STERIS. The word "STERIS" is in all caps and in a serif font. Below the word is a graphic of several horizontal blue lines that are curved to resemble waves.

# 510(k) Summary For Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Nonsterile

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact: Jennifer Nalepka Lead Regulatory Affairs Specialist Tel: [phone] Fax: [phone] Email: [e-mail]

July 30, 2019 Summary Date:

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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## STERIS Traditional 510(k) PREMARKET NOTIFICATION Endoscope Tip Protector

#### 1. Device Name

| Trade Name: | Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile |
|------------------------|--------------------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Endoscopic Storage Cover |
| Classification Name: | Endoscope and accessories |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | OCU |

#### 2. Predicate Device

K951104 Endo-boot - endoscope tip protector

#### 3. Description of Device

The Endoscope Tip Protector is a single-use molded protective cover to be used to protect endoscopes and medical/surgical instruments. The design of the Endoscope Tip Protector:

- Is composed on non-porous plastic material that allows for air flow
- . Has minimal contact points with the endoscope or medical/surgical instruments
- Fits a wide variety of devices: 4.9mm -15mm outer diameter ●
- Protects the distal tip of the endoscope or medical/surgical instrument during transport or storage.

The Endoscope Tip Protector is available both non-sterile and sterile.

#### 4. Intended Use

The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the purpose of protecting the endoscope's delicate lens and the endoscope's bending rubber during transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.

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#### 5. Technological Characteristic Comparison Table

The Endoscope Tip Protector is very similar to the Endo-Boot in intended use. The differences between the proposed and predicate devices are the design and material of construction. The design is different in the predicate compared to proposed because the predicate has a sponge-like configuration whereas the proposed has an open cage-like configuration. These differences do not raise any new concerns of safety and effectiveness when compared to the predicate device.

Table 1 summarizes the difference between the proposed device and the predicate.

| Feature | Endoscope Tip Protector<br>(Proposed) | Endo-Boot - endoscope<br>tip protector<br>(Predicate K951104) | Comparison |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Endoscope Tip<br>Protector is intended to be<br>used on the distal tip of an<br>endoscope for the purpose<br>of protecting the<br>endoscope's delicate lens<br>the endoscope's bending<br>rubber during transport<br>and storage. It may also<br>be used on the distal tip of<br>medical/surgical<br>instruments to protect<br>delicate<br>components/mechanisms. | The Endo-Boot is used as<br>a protective cover for the<br>tip of the endoscope or<br>other surgical instruments<br>(i.e. rigid laparoscope,<br>laparoscopic instruments)<br>during storage and<br>transport. The Endo-Boot<br>will aid in protecting the<br>lens and other delicate<br>components from damage. | Similar |
| Length | 10.2 cm | 14 cm | Similar |
| Endoscope<br>Compatible Outer<br>diameter (OD) | 4.9 mm - 15 mm | Small: 3.0 mm – 8.8 mm<br>Large: 8.8 mm - 15.0 mm | The Endoscope<br>Tip Protector is<br>"one size fits all"<br>and covers a wide<br>variety of<br>endoscope ODs<br>within the range of<br>the predicate<br>device |
| Biocompatible | Yes | Not performed | The predicate<br>Endo-boot -<br>endoscope tip<br>protector was not<br>evaluated for<br>biocompatibility<br>because it initially<br>was determined to<br>be non-patient |
| Feature | Endoscope Tip Protector<br>(Proposed) | Endo-Boot - endoscope<br>tip protector<br>(Predicate K951104) | Comparison |
| Supplied Sterile | Yes, also supplied non-<br>sterile | No | New sterile option<br>for users. |
| Packaging | Sterile version:<br>individually packaged in a<br>Tyvek pouch, 15 per box<br>Non-Sterile version:<br>individually packaged in a<br>poly bag, 50 per box | 25 per dispenser box, 2<br>dispenser boxes per case | All Endoscope Tip<br>Protectors are<br>packaged<br>individually. |
| Single Use | Yes | Yes | Identical |
| Disposable | Yes | Yes | Identical |
| Surface Contact<br>with Endoscope | Minimal; internal<br>diaphragm holds device in<br>place | Along entire Endo-Boot | Bumps on<br>diaphragm reduces<br>surface contact<br>with endoscope |
| Accessories | None | None | Identical |

Table 1. Predicate Device Comparison Table

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## STERIS Traditional 510(k) PREMARKET NOTIFICATION Endoscope Tip Protector

## 6. Description of Safety and Substantial Equivalence

Table 2 summarizes the verification activity that was performed with its respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the endoscope or medical/surgical instrument.

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## STERIS Traditional 510(k) PREMARKET NOTIFICATION Endoscope Tip Protector

| Testing | Acceptance Criteria | Proposed<br>Endoscope Tip<br>Protector |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Attachment and<br>Detachment Force | The Endoscope Tip Protector must be able<br>to be attached and detached with minimal<br>force | PASS |
| Scope Protection | The Endoscope Tip Protector must reduce<br>the impact force to the endoscope<br>compared to without protection | PASS |
| Transport Protection | The Endoscope Tip Protector must<br>remain on the endoscope during<br>transport | PASS |
| Longevity of Hold on<br>Endoscope | The Endoscope Tip Protector must<br>remain on the endoscope for at least 7<br>days | PASS |
| Irritation and Skin<br>Sensitization | Must meet ISO 10993-10: 2010 | PASS |
| Cytotoxicity | Must meet ISO 10993-5:2009 | PASS |
| Sterility | The Endoscope Tip Protector must have<br>a sterile version. | PASS |
| Packaging Validation | Sterile Packaging must meet ASTM F88/F88M-15, ASTM<br>F2096-11, and ASTM F1886/F1886M-16 | PASS |

## Table 2. Summary of Verification Activities

## 7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as or better than the legally marketed predicate device (K951104), Class II (21 CFR 876.1500), product code OCU.