REPROCESSED ENDOSCOPIC TROCARS

K121240 · Sterilmed, Inc. · NLM · Jun 11, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K121240
• Device Name: REPROCESSED ENDOSCOPIC TROCARS
• Applicant: Sterilmed, Inc.
• Product Code: NLM · Gastroenterology, Urology
• Decision Date: Jun 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs.

Device Story

Reprocessed endoscopic trocars consist of a sleeve and obturator (bladeless or dilating tip) of varying lengths/diameters. Used in general, abdominal, thoracic, and gynecologic surgery to provide a pathway for minimally invasive instruments. Operated by surgeons in clinical settings. Device facilitates observation, dissection, cutting, repair, and tissue manipulation. Reprocessing involves cleaning and sterilization of previously used devices to restore functionality. Healthcare providers use the device to access internal cavities; benefits include enabling minimally invasive surgical access.

Clinical Evidence

Bench testing only. No clinical data. Validation included cleaning, sterilization (ISO 11135, USP <71>), biocompatibility (ISO 10993), ethylene oxide residuals (ISO 10993-7), packaging (ASTM D 4169, F 88, F 2096), shelf life (ASTM 1980-07), and functional performance (simulated use, visual inspection, fatigue testing).

Technological Characteristics

Sterile, single-use reprocessed endoscopic instrument. Components: sleeve and obturator (bladeless or dilating tip). Materials identical to predicate (except non-patient contact absorbent ring). Standards: ISO 11135, ISO 10993, ASTM D 4169, ASTM F 88, ASTM F 2096, ASTM 1980-07. Sterilization: Ethylene oxide.

Indications for Use

Indicated for patients undergoing general, abdominal, thoracic, gynecologic, or other minimally invasive surgical procedures requiring a pathway for instrument entry into body organs or cavities.

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

• Ethicon Endo-Surgery ENDOPATH® XCEL™ With OPTIVIEW® Technology Trocars (K032676)

Submission Summary (Full Text)

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JUN 1 1 2012

<121240

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### 510(K) PREMARKET NOTIFICATION SUBMISSION 23 APRIL 2012 For Reprocessed Endoscopic Trocars

#### SUMMARY AND CERTIFICATION II.

- 510(k) Summary A.
Sterilmed, Inc.

Contact Person:

Submitter:

Jason Skramsted 11400 73td Avenue North Maple Grove, MN 55369 Phone: [phone] Fax: [phone]

| Date Prepared: | 23 April 2012 |
|------------------------|--------------------------------|
| Trade Name: | Reprocessed Endoscopic Trocars |
| Classification Name: | Endoscope and accessories |
| Classification Number: | Class II, 21 CFR 876.1500 |
| Product Code: | NLM |

| Predicate<br>Devices: | The reprocessed endoscopic trocars are substantially equivalent to Ethicon Endo-Surgery ENDOPATH®<br>XCEL™ With OPTIVIEW® Technology Trocars (K032676). |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator that is available<br>in varying lengths and diameters. The obturator may be bladeless or dilating tip. Reprocessed trocars are<br>devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during<br>general, abdominal, thoracic, gynecologic, or other minimally invasive surgical procedures. |
| Intended Use: | The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive<br>instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally<br>invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation<br>of internal tissues and/or organs. |
| Technological<br>Characteristics: | The reprocessed endoscopic trocars are identical to the predicate devices in design, materials of construction<br>(except for the absorbent ring which is non-patient contact), and intended use. There are no changes to the<br>clinical applications, patient population, performance specifications, or method of operation. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed endoscopic trocars were tested to demonstrate appropriate functional<br>characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures<br>as well as device packaging, In addition, the manufacturing process includes visual and validated functional<br>testing of all products produced. |
| Summary of<br>Non-clinical<br>Tests<br>Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<br><71>), biocompatibility testing (ISO 10993), ethylene oxide residual testing (ISO 10993-7), packaging<br>validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM 1980-07). In<br>addition, validation of functional performance (bench testing) was performed through simulated use, visual<br>inspection, fatigue testing, and function testing, Performance testing shows the reprocessed endoscopic trocar<br>to perform as originally intended. |
| Conclusion: | Sterilmed concludes that the reprocessed endoscopic trocars are safe, effective, and substantially equivalent to<br>the predicate devices, Ethicon Endo-Surgery ENDOPATH® XCEL™ With OPTIVIEW® Technology Trocars<br>(K032676), as described in this premarket notification submission. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 1 2022

Sterilmed. Incorporated % Mr. Jason Skramsted, RAC 11400 73td Avenue, North Maple Grove, Minnesota 55369

Re: K121240

Trade/Device Name: Reprocessed Endoscopic Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NLM Dated: April 23, 2012 Received: April 24, 2012

Dear Mr. Skramsted:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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. You must

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Page 2 - Mr. Jason Skramsted

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Madle Al millum

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the word "STERILMED" in a simple, sans-serif font. To the left of the word is a circular graphic with a stylized design. The text and graphic appear to be part of a logo or brand identity.

# 510(K) PREMARKET NOTIFICATION SUBMISSION 23 APRIL 2012

For Reprocessed Endoscopic Trocars

# Indications for Use

510(k) Number (if known):

Device Name: Reprocessed Endoscopic Trocars

Indications for Use:

The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs.

Prescription Use X (Part 21 CFR 801 Subpart D)

### AND/OR .

Over-The-Counter Use . (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121240

CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.

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K121240-List of device models included in this submission.

and the control of the country of the county of

| Manufacturer | Model # | Device Description |
|--------------------------|---------|------------------------------------------------------------|
| Ethicon Endo-<br>Surgery | 2B5ST | Bladeless Trocars (D 5mm, L 75mm, Stability<br>Sleeve) |
| | 2B5LT | Bladeless Trocars (D 5mm, L 100mm, Stability<br>Sleeve) |
| | 2D5ST | Dilating Tip Trocars (D 5mm, L 75mm, Stability<br>Sleeve) |
| | 2D5LT | Dilating Tip Trocars (D 5mm, L 100mm, Stability<br>Sleeve) |
| | 2CB5ST | Universal Sleeves (D 5mm, L 75mm, Stability<br>Sleeve) |
| | 2CB5LT | Universal Sleeves (D 5mm, L 100mm, Stability<br>Sleeve) |

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