AIRLIFT BALLOON RETRACTON SYSTEM

K962104 · Origin Medsystems, Inc. · GCJ · Sep 11, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962104
• Device Name: AIRLIFT BALLOON RETRACTON SYSTEM
• Applicant: Origin Medsystems, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Airlift Jr.™ Balloon Retraction System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used as an alternative to insufflation for retracting organs and tissues thus creating a working cavity for endoscopic surgery. The Airlift Jr.™ Balloon Retraction System is used in conjunction with the Laparolift™ previously cleared under premarket notification k921103 September 9, 1993.

Device Story

Single-use balloon retraction system for minimally invasive surgery. System includes inflatable balloon, sheath, tether, strap, inflation bulb, and attachment assembly (connector drape, tool holder). Device inserts through small incision; attaches to Laparolift mechanical distention arm. Balloon inflates to lift/retract organs and tissues, creating working cavity without gas insufflation. Operated by surgeon in OR. Provides mechanical space creation; replaces gas insufflation; reduces potential complications associated with gas insufflation.

Clinical Evidence

No clinical data. Substantial equivalence based on identical materials and technological characteristics to previously cleared predicate device.

Technological Characteristics

Components: polyurethane coated nylon (balloon, tether, strap), polyurethane (sheath, inflation tube). Mechanical retraction principle. Single-use. Sterile. Dimensions: 4.1-inch deployed balloon diameter. Used with mechanical Laparolift arm.

Indications for Use

Indicated for patients undergoing endoscopic surgery where retraction of organs and tissues is required to create a working cavity as an alternative to gas insufflation. Contraindicated when endoscopic surgery is contraindicated.

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

• ORIGIN Airlift™ Balloon Retraction System (K942678)

Reference Devices

• Laparolift™ (K921103)

Submission Summary (Full Text)

{0}

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION
Airlift Jr.™ Balloon Retraction System
SEP 11 1996
Class II
K962104

# 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.

## 21 CFR §807.92 a(1)

Submitter: ORIGIN® Medsystems, Inc.
135 Constitution Avenue
Menlo Park, CA 94025
[phone]
contact person: Anthony Durso
date prepared: May 24, 1996

## 21 CFR §807.92 a(2)

Trade name: Airlift Jr.™ Balloon Retraction System

Common name: Retraction Instrument
Classification name: Retraction Instrument

## 21 CFR §807.92 a(3)

**Identification of predicate(s):** Substantial equivalence for the Airlift Jr.™ Balloon Retraction System is based on its similarities to predicate device: the ORIGIN Airlift™ Balloon Retraction System. The Airlift Jr.™ Balloon Retraction System, shares the identical material, and technological characteristics as the predicate device. The Airlift Jr.™ Balloon Retraction System is also similar in intended use.

## 21 CFR §807.92 a(4)

**Device Description-parts and function/concept:** The Airlift Jr.™ Balloon Retraction System is a single-use device which consist of an inflatable balloon, balloon sheath, tether and scrap, inflation bulb, and an attachment assembly which includes a connector drape and tool holder. The Airlift Jr.™ Balloon Retraction System is provided sterile and is developed to be used in conjunction with an Origin Laparolift Retraction System. This device is used to lift and retract organs and tissues to provide a space for endoscopic surgery without the use of gas insufflation.

Page 5

{1}

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION
Airlift Jr.™ Balloon Retraction System
Class II

# 21 CFR §807.92 a(4)

## Device Description—parts and function/concept: continued

The retraction of organs and tissues is achieved by first making a small incision then inserting the Airlift Balloon device. The Airlift Balloon is then attached to the Laparolift (mechanical distention arm) by means of the attachment assembly (tool holder and connector drape). The Laparolift is used to lift the Airlift Balloon device, and therefore the organs and tissues are raised to the height typically achieved by gas insufflation thus creating a working cavity for surgery. This function is equivalent to those described for the predicate device: Airlift™ Balloon Retraction System k942678, same as (Lifting Distention Balloon System, the predicate device will be referred to hence forth as Airlift™ Balloon Retraction System). The new device: Airlift™ Jr. has a balloon size of 4.1 inches deployed. The predicate device: Airlift™ Balloon Retraction System has a balloon size of 5.4 inches deployed. (See comparable chart on page 16-17).

Page 6

{2}

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION
Airlift Jr.™ Balloon Retraction System
Class II

Device Description-materials/physical properties: a table of the patient contact components, with their respective materials, is provided below. The connector drape, tool holder and Laparolift (mechanical distention) arm are the same as those cleared in the K921103, 1/15/93.

| Component Name | Patient Contact | Material | Predicate |
| --- | --- | --- | --- |
| Inflation Balloon | yes | polyurethane coated nylon | Airlift™ Balloon Retraction System, k942678 |
| Containment Sheath | yes | polyurethane | Airlift™ Balloon Retraction System, k942678 |
| Tether and Strap | yes | polyurethane coated nylon | Airlift™ Balloon Retraction System, k942678 |
| Tube Inflation | yes | polyurethane | Airlift™ Balloon Retraction System, k942678 |

The listed parts are currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness.

## 21 CFR §807.92 a(5)

Intended use and relationship to predicate(s): The Airlift Jr.™ Balloon Retraction System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used as an alternative to insufflation for retracting organs and tissues thus creating a working cavity for endoscopic surgery. The Airlift Jr.™ Balloon Retraction System is used in conjunction with the Laparolift™ previously cleared under premarket notification k921103 September 9, 1993. The predicate device (Airlift™ Balloon Retraction System) has applications in laparoscopic surgery and is indicated and may be used as an alternative to insufflation for retracting organs and creating a working cavity for laparoscopic surgery. The predicate device is also used in conjunction with the Laparolift™.

Page 7

{3}

ORIGIN Medsystems, Inc.
PREMARKET NOTIFICATION
Airlift Jr.™ Balloon Retraction System
Class II

The Airlift Jr.™ Balloon Retraction System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

## CFR §807.92 a(6)

### Technological characteristics and relationship to predicate(s):

The Airlift Jr.™ Balloon Retraction System is substantially equivalent to the Airlift™ Balloon Retraction System previously cleared product. The Airlift Jr.™ Balloon Retraction System shares the identical function, technological characteristics and materials as the predicate device.

## 21 CFR §807.92 b

This submission’s determination of substantial equivalence is based on similarities to the predicate devices in terms of intended uses, materials, and technological characteristics.

## 21 CFR §807.92 c

In accordance with the specifications of this subsection, this summary (4 pages) is its own section, and has been clearly identified as such.

Page 8