(222 days)
No
The device description and intended use focus on a manually manipulated mechanical device for tissue dissection, with no mention of AI/ML capabilities or data processing.
No.
The device is used to dissect tissue and provide surgical access, which is a surgical tool function, not a therapeutic treatment.
No
The device is described as a surgical balloon dissector used to separate layers of connective tissue for surgical access. While its cannula portion can provide access for "diagnostic instruments," the device itself is not stated to perform diagnostic functions. Its primary role is for surgical dissection, not diagnosis.
No
The device description clearly outlines physical components such as a balloon, center rod, handle, suction/fill assembly, and potentially a cannula, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dissect layers of connective tissue along natural planes of separation" for surgical access. This is a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is a surgical tool (balloon dissector, cannula) used for physical manipulation of tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely surgical and mechanical.
N/A
Intended Use / Indications for 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.
Indications:
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, 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.
Product codes
Not Found
Device Description
The Spacemaker® Serial Surgical Balloon Dissector device is a disposable, handheld, manually manipulated surgical balloon dissection 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Any area of the body where it is necessary to separate the layers of connective tissue for surgical access.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
KS62702
Attachment 4
Section 10.0: 510(K) Summary
FEB 1 9 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 ).
Contact Person 10.1
Cathleen Mantor General Surgical Innovations, Inc. 3172A Porter Drive Palo Alto, CA 94304 (415) 812-9730 (415) 812-9731 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
Common Name 10.4
Surgical Balloon Dissector with or without Cannula
Predicate devices 10.5
- K944418 Spacemaker® and Spacemaker® II Surgical Balloon Dissector and Cannula, Class II
- Spacemaker® and Spacemaker® II Surgical Balloon Dissector with and K951878 without a Cannula, Class II
01/16/97 23 (page number from original submission)
1
Attachment 4
Device Description 10.6
The Spacemaker® Serial Surgical Balloon Dissector device is a disposable, handheld, manually manipulated surgical balloon dissection 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.
2
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 |
25 (page number from original submission)
3
Testing in Support of Substantial Equivalence Determination 10.9
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).