SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA

K962702 · General Surgical Innovations · GCJ · Feb 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K962702
• Device Name: SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA
• Applicant: General Surgical Innovations
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Spacemaker® Serial Surgical Balloon Dissector and the predicate devices is to dissect layers of connective tissue along natural planes of separation. The cannula portion of the device is intended to provide access for operative and diagnostic instruments for the duration of the operative procedure.

Device Story

Disposable, handheld, manually manipulated surgical balloon dissector; consists of balloon, center rod, handle, and suction/fill assembly. Used in OR by surgeons to dissect connective tissue along natural planes. Device allows multiple inflations/deflations per procedure using saline or air (10-1000cc). Hollow center rod version accommodates endoscopic visualization accessories. Optional cannula provides access for operative/diagnostic instruments. Benefits include creating surgical space for minimally invasive procedures.

Clinical Evidence

Bench testing only. Performance bench tests verified that modifications (multiple inflation capability, new silicone material, elliptical balloon shape) do not affect safety or efficacy compared to predicate devices. Biocompatibility testing performed per ANSI/AAMI 10993-1.

Technological Characteristics

Materials: Plastic, stainless steel, and silicone (compliant with ANSI/AAMI 10993-1). Principle: Manual balloon inflation/deflation for tissue dissection. Form factor: Handheld, disposable, with optional cannula and endoscopic visualization port. Balloon volume: 10-1000cc. Inflation medium: Saline or air. Configurations: Solid or hollow center rod; various balloon profiles (kidney, clover, horseshoe, semi-round, U-shaped, elliptical).

Indications for Use

Indicated for any area of the body where it is necessary to separate layers of connective tissue for surgical access, including general, laparoscopic, endoscopic, plastic, reconstructive, aesthetic surgery, and vascular use for exposure of superficial veins of upper/lower extremities; excludes arterial, deep, or non-extremity structures.

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

• Spacemaker® and Spacemaker® II Surgical Balloon Dissector and Cannula (K944418)
• Spacemaker® and Spacemaker® II Surgical Balloon Dissector with and without a Cannula (K951878)

Submission Summary (Full Text)

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K962702
Attachment 4
Section 10.0: 510(K) Summary
FEB 19 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

## 10.1 Contact Person

Cathleen Mantor
General Surgical Innovations, Inc.
3172A Porter Drive
Palo Alto, CA 94304
[phone]
[phone] fax

## 10.2 Date Summary Prepared

July 9, 1996

## 10.3 Trade Name

Spacemaker® Serial Surgical Balloon Dissector, Class II
Spacemaker® Serial Surgical Balloon Dissector with Cannula, Class II
Spacemaker® Serial Surgical Balloon Dissector with Visualization, Class II
Spacemaker® Serial Surgical Balloon Dissector with Visualization and Cannula, Class II

## 10.4 Common Name

Surgical Balloon Dissector with or without Cannula

## 10.5 Predicate devices

K944418 Spacemaker® and Spacemaker® II Surgical Balloon Dissector and Cannula, Class II
K951878 Spacemaker® and Spacemaker® II Surgical Balloon Dissector with and without a Cannula, Class II
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Attachment 4

## 10.6 Device Description

The Spacemaker® Serial Surgical Balloon Dissector device is a disposable, handheld, manually manipulated surgical balloon dissection device. The device consists of a balloon, center rod, handle, and suction/fill assembly. The device can be supplied either with a solid center rod or with a hollow center rod. The hollow center rod allows for the insertion of an endoscopic visualization accessory, if desired. Both versions can be inflated and deflated multiple times during a procedure.

The device can be supplied with or without a cannula. The cannula provides access for operative and diagnostic instrumentation for the duration of the surgical procedure.

This submission seeks clearance for the Spacemaker® Serial Surgical Balloon Dissector to be supplied in four configurations as follows:

- Spacemaker® Serial Surgical Balloon Dissector, Class II
- Spacemaker® Serial Surgical Balloon Dissector with Cannula, Class II
- Spacemaker® Serial Surgical Balloon Dissector with Visualization, Class II
- Spacemaker® Serial Surgical Balloon Dissector with Visualization and Cannula, Class II

## 10.7 Intended Use

The intended use of the Spacemaker® Serial Surgical Balloon Dissector is the same as the predicate devices (K944418, K951878). The intended use of the Spacemaker® Serial Surgical Balloon Dissector and the predicate devices is to dissect layers of connective tissue along natural planes of separation. The cannula portion of the device is intended to provide access for operative and diagnostic instruments for the duration of the operative procedure.

01/16/97
24 (page number from original submission)

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Attachment 4

# 10.8 Comparison to Predicate Devices

| Point of Comparison | Spacemaker® and Spacemaker® II Surgical Balloon Dissector and Cannula (K944418) | Spacemaker® and Spacemaker® II Dissector with and without Cannula (K951878) | Spacemaker® Serial Surgical Balloon Dissector |
| --- | --- | --- | --- |
| Intended Use | Dissect layers of connective tissue along natural planes of separation. | Dissect layers of connective tissue along natural planes of separation. | Dissect layers of connective tissue along natural planes of separation. |
| Indications | Any area of the body where it is necessary to separate the layers of connective tissue for surgical access. | Any area of the body where it is necessary to separate the layers of connective tissue for surgical access. | Any area of the body where it is necessary to separate the layers of connective tissue for surgical access. |
| Examples where surgical dissection of natural tissue planes can provide surgical access: | General, laparoscopic, and endoscopic surgery | General, laparoscopic, endoscopic, plastic and reconstructive, including aesthetic surgery | General, laparoscopic, endoscopic, plastic and reconstructive, including aesthetic surgery and vascular use for the exposure of superficial veins of the upper and/or lower extremities; no arterial nor deep nor non-extremity structure would be targeted. |
| Supplied | Single patient use; Disposable | Single patient use; Disposable | Single patient use; Disposable |
| Balloon Inflations Per Procedure | Single | Single | Multiple |
| Principle of Operation | Handheld, manually manipulated surgical instrument | Handheld, manually manipulated surgical instrument | Handheld, manually manipulated surgical instrument |
| Balloon Volume Range | 200-1500cc saline inflation | 10-2500cc saline or air inflation | 10-1000cc saline or air inflation |
| Packaging Configuration | Dissector with cannula | Dissector with cannula or Dissector without cannula | Dissector with cannula or Dissector without cannula |
| Balloon Shapes | Include kidney, clover, horseshoe, semi-round, and U-shaped profiles | Include kidney, clover, horseshoe, semi-round, and U-shaped profiles | Include kidney, clover, horseshoe, semi-round, U-shaped and elliptical profiles |
| Materials | Plastic, Stainless steel | Plastic, Stainless steel | Plastic, Stainless steel |
| Balloon Cover | Yes | Yes | No |
| Center Rod | Rigid or flexible | Rigid or flexible | Rigid or flexible |
| Endoscopic Visualization | No (Spacemaker®) Yes (Spacemaker® II) | No (Spacemaker®) Yes (Spacemaker® II) | Optional |
| Cannula Sizes (mm) | 10/11 or 12/13 | 10/11, 12/13, or No Cannula | 10/11, 12/13, or No Cannula |

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Attachment 4

## 10.9 Testing in Support of Substantial Equivalence Determination

Results of performance bench tests verify that the modifications do not affect the safety or efficacy of the Spacemaker® Serial Surgical Balloon Dissector compared to the predicate devices.

There is one material used in the Spacemaker® Serial Surgical Balloon Dissector (which was not used in the predicate devices). The remainder of the materials were used in the predicate devices. The material (a well known and commonly used silicone) meets the biocompatibility test requirements as defined in ANSI/AAMI 10993-1 (ISO 10993-1).

01/16/97

26 (page number from original submission)