THE ESPINER SAC OR E SAC

K111845 · Espiner Medical Limited · GCJ · Sep 26, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K111845
• Device Name: THE ESPINER SAC OR E SAC
• Applicant: Espiner Medical Limited
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.

Device Story

The Espiner Tissue Retrieval System comprises a family of sterile, single-use impervious sacs, optionally used with a dedicated introducer sleeve. During laparoscopic surgery, the surgeon inserts the sac into the body cavity to encapture target organs, tissues, or fluids. Once the specimen is contained, the sac is removed from the body cavity through the laparoscopic port. The device facilitates safe specimen extraction, minimizing the risk of contamination or spillage within the body cavity. It is intended for use by surgeons in a clinical or hospital setting.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing demonstrated that the device is identical to the predicate in safety and effectiveness.

Technological Characteristics

Impervious sac system, sterile, single-use. Includes optional introducer sleeve. Principle of operation is mechanical containment and retrieval of tissue/fluid. No electronic components, software, or energy sources.

Indications for Use

Indicated for the encapture and removal of organs, tissues, or fluids from the body cavity during laparoscopic surgery in patients undergoing such procedures.

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

• Anchor Espiner Tissue Retrieval System (K982073)

Submission Summary (Full Text)

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

K111845

Espiner Medical Ltd. Traditional 510(k) For the Espiner Tissue Retrieval System

Page 1 of 4

7311

ಲ್ಲ
ಕ

#### 510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's Name:

Espiner Medical Ltd

Submitter's Address:

Espiner Medical Ltd Yeo Bank 3, Kenn Road, Clevedon, North Somerset, United Kingdom, BS21 6TH

Telephone [phone] Fax [phone]

Establishment Registration Number:

Still to be established

Contact Person:

Edwin Lindsay

Telephone [phone]

### Date Prepared:

15th August 2011

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

K111 845

Page 2 of

Espiner Medical Ltd. Traditional 510(k)

For the Espiner Tissue Retrieval System

### 510(k) Summary

# Device Classification Information: .

| Regulation<br>Number | Device Name | Device<br>Class | Product<br>Code | Classification<br>Panel |
|----------------------|-------------------------------------------|-----------------|-----------------|------------------------------|
| 876.1500 | Laparoscope, General &<br>Plastic Surgery | Class 2 | GCJ | General &<br>Plastic Surgery |

### Device Trade Name:

్

The Espiner Tissue Retrieval System

### Device Common Name:

The Espiner Sac or E Sac

Note: An accessory to the device is the 'Espiner introducer sleeve'. It is also a class II device.

#### Intended Use:

The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.

. දිනු

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

K111845

Espiner Medical Ltd. Traditional 510(k)

Page 3 of 4

For the Espiner Tissue Retrieval System

# 510(k) Summary

# Summary of Substantial Equivalence:

The predicate device family is the same product (not similar but identical) already approved with a 510(k) (K982073). Espiner Medical Ltd is the original manufacturer of the product family that is currently approved and being distributed in the United States by the Anchor Products Company.

A comparison is presented in the table below:

| Property | New Device:<br>Espiner Tissue Retrieval System | Anchor Espiner Tissue Retrieval System |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Manufacturer | Espiner Medical Ltd | Anchor Products Company |
| Device Trade Name | The Espiner Tissue Retrieval System | Anchor Espiner Tissue Retrieval System |
| 510(K) Number | N/A | K982073 |
| Product Code | GCJ | GCJ |
| Device Common<br>Name | The Espiner Sac or E Sac | Anchor Espiner Tissue Retrieval Pouch |
| Device<br>Classification name | Laparoscope, General & Plastic Surgery | Laparoscope, General & Plastic Surgery |
| Device<br>Classification | Class II | Class II |
| Intended Use | The Espiner Tissue Retrieval System<br>consists of a family of impervious sacs<br>which are sterile single use devices that can<br>be used alone or with a dedicated introducer<br>system for the encapture and removal of an<br>organ, tissue or fluid from the body cavity<br>during laparoscopic surgery | The Anchor Espiner Tissue Retrieval<br>System is a sterile disposable pouch that<br>can be used with a dedicated introducer<br>system for the encapture and removal of an<br>organ, tissue or fluid from the body cavity<br>during laparoscopic surgery |

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

K11845

ge 4 of 4

Espiner Medical Lt Traditional 510(k For the Espiner Tissue Retrieval System

### 510(k) Summary

## Device Description:

ਦੇ

The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.

#### Technological Characteristics:

A comparative review of the Espiner Tissue Retrieval System with the predicate devices found that the technological characteristics, performance and principle of operation were substantially equivalent (identical).

## Performance/Physical Data:

Bench testing demonstrated that the safety and effectiveness of the TFT Espiner Tissue Retrieval System is equivalent (identical) to the predicate devices.

### Safety and Effectiveness:

The Espiner Tissue Retrieval System utilises similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate devices, the Espiner Tissue Retrieval System indicated no adverse indications or results. It is our determination that the Espiner Tissue Retrieval System is safe, effective and performs within its design specifications and is substantially equivalent (identical) to the predicate device.

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

Image /page/4/Picture/1 description: The image shows the seal of the United States Department of Health and Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of an abstract symbol, consisting of three horizontal lines that curve downwards. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

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

Espiner Medical Limited % Compliance Solutions (Life Sciences) Ltd. Mr. Edwin Lindsay 116 Almond Road, Cumbernauld Glasgow. United Kingdom G673LW

Re: K111845

Trade/Device Name: The Espiner Tissue Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 18, 2011 Received: June 29, 2011

SEP 2 6 2011

Dear Mr. Lindsay:

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

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

Page 2 - Mr. Edwin Lindsay

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 (23 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/ReportalProblem/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,

Mark N. Melkerson

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

Enclosure

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

Espiner Medical Ltd. Traditional 510(k) For the Espiner Tissue Retrieval System

Indications for Use

510(k) Number (if known):

Device Name: The Espiner Tissue Retrieval System

Indications for Use:

The Espiner Tissue Retrieval System consists of a family of impervious sacs which are sterile single use devices that can be used alone or with a dedicated introducer system for the encapture and removal of an organ, tissue or fluid from the body cavity during laparoscopic surgery.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Natheol Forman
(Division Sign Off)

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

510(k) Number K111845