SUMO ACCESS AND TISSUE RESECTION SYSTEM

K103155 · Apollo Endosurgery, Inc. · ODC · Oct 28, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103155
• Device Name: SUMO ACCESS AND TISSUE RESECTION SYSTEM
• Applicant: Apollo Endosurgery, Inc.
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Oct 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SuMO™ Access and Tissue Resection System is intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures such as removal of flat polyps. The Injection Needle is intended for endoscopic injection of solutions such as saline as a procedural aid in endoscopic procedures. The Tunneling Balloon is intended for soft tissue separation and dilation during endoscopic procedures. The Dilation Balloon is intended for soft tissue separation and dilation during endoscopic procedures. The Tissue Resection Tool is intended for endoscopic resection in the gastrointestinal tract. The SuMO™ Snare is intended to remove polyps and small tumors from the gastrointestinal tract.

Device Story

Single-use endoscopic system for gastrointestinal soft tissue management; includes injection needle, tunneling/dilation balloons, tissue resection tool, and snare. Operated by physicians during endoscopic procedures. System facilitates tissue access, separation, and resection (e.g., flat polyps, small tumors). Components used to inject solutions, dilate tissue, and mechanically remove lesions. Provides clinical benefit by enabling minimally invasive endoscopic resection. No automated processing or software components.

Clinical Evidence

Bench testing only. Testing included dimensional analysis, inflation/deflation performance, balloon size/reloading, resistivity, endoscope compatibility, electrical safety, and electromagnetic compatibility. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous toxicity) confirmed material safety. No clinical data provided.

Technological Characteristics

Single-use endoscopic accessory system. Components: injection needle, tunneling balloon, dilation balloon, tissue resection tool, snare. Materials are biocompatible and previously cleared. Sterilization via validated ETO cycle (SAL 10^-6). No software or electronic processing components.

Indications for Use

Indicated for patients undergoing endoscopic gastrointestinal procedures requiring soft tissue access, dissection, and resection, including removal of flat polyps and small tumors.

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

• Injectra Injection Needle (K061222)
• Electrocautery Dilation Balloon (K082114)
• Spacemaker Balloon (K042412)
• Polypectomy Snare (K943935)
• Duette Muscosectomy (K050578)

Submission Summary (Full Text)

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

# OCT 2 8 2011

#### 510(k) Summary

General Information

| Classification | Class II |
|----------------|-----------------------------------------------------------------------------------------------------------|
| Trade Name | SuMO Access and Tissue Resection System |
| Submitter | Apollo Endosurgery, Inc.<br>7000 Bee Cave Road<br>Suite 350<br>Austin, Texas 78746<br>Tel: [phone] |
| Contact | Greg Mathison |
| Date Prepared | October 28, 2011 |

#### Indications for Use

The SuMO™ Access and Tissue Resection System is intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures such as removal of flat polyps.

The Injection Needle is intended for endoscopic injection of solutions such as a procedural aid in endoscopic procedures.

The Tunneling Balloon is intended for soft tissue separation and dilation during endoscopic procedures.

The Dilation Balloon is intended for soft tissue separation and dilation during endoscopic procedures.

The Tissue Resection Tool is intended for endoscopic resection in the gastrointestinal tract.

The SuMO™ Snare is intended to remove polyps and small tumors from the gastrointestinal tract.

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

# Predicate Devices

| K061222 | Injectra Injection Needle | Medi-Globe Corp |
|---------|---------------------------------|--------------------|
| K082114 | Electrocautery Dilation Balloon | Apollo Endosurgery |
| K042412 | Spacemaker Balloon | US Surgical |
| K943935 | Polypectomy Snare | Medi-Globe Corp |
| K050578 | Duette Muscosectomy | Cook |

#### Device Description

The Apollo Endosurgery SuMO Access and Tissue Resection System is a single-use system intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures.

The system is comprised of five component devices:

- Injection Needle ●
- Tunneling Balloon .
- Dilation Balloon .
- Tissue Resection Tool .
- SuMO Snare ●

## Materials

All materials used in the manufacture of the SuMO Access and Tissue Resection System are suitable for this use and have been used in previously cleared products.

Apollo conducted GLP biocompatibility testing including:

- . Cytotoxicity
- Sensitization .
- Intracutaneous Toxicity .

The materials were found to be biocompatible and suitable for this use.

# Sterilization

The SuMO System is sterilized in a validated ETO cycle with a resulting SAL of 10°. ETO residual testing was conducted and met FDA and international requirements.

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

# Testing

Product testing was completed and met the acceptance criteria. Testing was completed, including: dimensional, inflation/deflation, balloon size and reloading, resistivity and endoscope compatibility.

Electrical safety and electromagnetic compatibility testing was also performed with the products meeting the requirements of the test standards.

#### Summary of Substantial Equivalence

The SuMO Access and Tissue Resection System is equivalent to the features of the The table below compares the basic attributes of the SuMO System predicate products. with other legally marketed predicate devices.

| Feature/Information | Apollo SuMO System | Predicate Devices |
|-------------------------|--------------------|-------------------|
| FDA Classification | Class II | Class II |
| Regulation number | 876.1500 | 876.1500 |
| Materials | Biocompatible | Biocompatible |
| Endoscopic Use | Yes | Yes |
| Endoscope Compatibility | Same | Same |
| Needle Gauge | Same | Same |
| Working Length | Same | Same |
| Catheter Diameter | Same | Same |
| Electrocautery Type | Same | Same |
| Dilating Balloon | Same | Same |
| Provided Sterile | Same | Same |
| Method of Sterilization | Same | Same |
| Single Use | Same | Same |
| Packaging | Same | Same |

Product Comparison Table

#### Conclusion

The indications for use, basic overall function, clinical application, methods of manufacturing, and materials used are substantially equivalent.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

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

OCT 2 8 2011

Mr. Gregory Mathison Vice President, Regulatory Affairs Apollo Endosurgery, Inc. 7000 Bee Caves Rd., Suite 350 AUSTIN TX 78746

Re: K103155

Trade/Device Name: Apollo SuMO Access and Tissue Resection System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: September 29, 2011 Received: October 4, 2011

Dear Mr. Mathison:

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 10 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 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

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

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,

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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

# Indications for Use

510(k) Number (if known): K103155

Device Name: Apollo SuMO Access and Tissue Resection System

Indications for Use:

The SuMO™ Access and Tissue Resection System is intended to access, dissect, and resect soft tissue in endoscopic gastrointestinal procedures such as removal of flat polyps.

The Injection Needle is intended for endoscopic injection of solutions such as saline as a procedural aid in endoscopic procedures.

The Tunneling Balloon is intended for soft tissue separation and dilation during endoscopic procedures.

The Dilation Balloon is intended for soft tissue separation and dilation during endoscopic procedures.

The Tissue Resection Tool is intended for endoscopic resection in the gastrointestinal tract.

The SuMO™ Snare is intended to remove polyps and small tumors from the gastrointestinal tract.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

![]()

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arym M. Khan

Division of Reproductive, Gastro-Renal
Urological Devices
510(k) Number K103155

Page 1 of 1