The device is indicated for any area of the body where it is necessary to separate the layers of connective tissue for surgical access. The intended use of the Spacemaker® Surgical Balloon Dissectors is to create a operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal (including preperitoneal), or subcutaneous extremity or thoracic space.

The indications for use include dissection of tissue for the following surgical procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery, including aesthetic surgery; vascular surgery for the exposure of superficial vessels of the upper and/or lower extremities (no deep structure would be targeted), including the saphenous vein and femoral vessels; thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall; procedures in the extraperitoneal space involving dissection of tissue layers allowing exposure of structures including: adrenals, bone, spine, lymph nodes, and kidneys.

Examples of specific surgical procedures the Spacemaker® Surgical Balloon Dissectors may be used to facilitate tissue dissection include: fascial lavers between the skin and peritoneum. hernia repair, varicocele dissection, sympathectomy, lymph node dissection, urethropexy, subfascial perforator vein ligation, access to the saphenous vein and femoral vessels, retroperitoneal access to the anterior spine, access for long bone plating.

The cannula portion of the device is intended to provide access for surgical and diagnostic instruments for the duration of the operative procedure.

Device Description

The Spacemaker® Surgical Balloon Dissector devices are handheld, manually manipulated surgical balloon dissectors. The devices can be supplied with either a solid center rod or a hollow center rod. The hollow center rod allows for the insertion of an endoscopic visualization accessory, if desired. The devices can be supplied with or without a cannula. The cannula provides access for operative and diagnostic instrumentation for the surgical procedure.

AI/ML Overview

The provided 510(k) summary for K973046 does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/medical imaging device submissions.

This 510(k) submission is for the "Spacemaker® Surgical Balloon Dissector" and related devices. The basis for substantial equivalence is that the devices have the "same principle of operation as the predicate devices" and that "there are no changes to any of the Spacemaker® devices." Furthermore, the submission explicitly states:

"No functional bench testing was performed for this submission because no tests were necessary to substantiate the safety, performance or substantial equivalence."

Therefore, I cannot populate the requested table or answer most of the questions about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided document. The device's clearance was based on its established substantial equivalence to predicate devices without new performance testing being deemed necessary.

However, I can provide the following based on the available information:

Summary based on K973046:

The K973046 submission for the Spacemaker® Surgical Balloon Dissector devices was granted clearance based on substantial equivalence to existing predicate devices, rather than through a performance study against specific acceptance criteria. The submission explicitly states that no functional bench testing was performed due to the lack of necessary substantiation for safety, performance, or substantial equivalence. Therefore, there are no reported acceptance criteria or a study proving the device meets acceptance criteria in the context of new performance testing.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not applicable. The submission states "No functional bench testing was performed for this submission because no tests were necessary to substantiate the safety, performance or substantial equivalence." Substantial equivalence was based on the devices having the same principle of operation and no changes from predicate devices.	Not applicable. No new performance data was generated or reported as testing was deemed unnecessary.

2. Sample size used for the test set and the data provenance:

Not applicable. No test set was used for a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No test set requiring expert-established ground truth was used.

4. Adjudication method for the test set:

Not applicable. No test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a surgical instrument and not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a surgical instrument, not an algorithm. No standalone performance study was done.

7. The type of ground truth used:

Not applicable. No performance study requiring ground truth was conducted. Substantial equivalence was based on device design and intended use matching predicate devices.

8. The sample size for the training set:

Not applicable. This submission does not involve a machine learning model or a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set or associated ground truth was established for this submission.

Summary

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K973046

Appendix 4

510(k) Summary

JAN 16 1998

Cathleen Mantor Contact Person: 1.
General Surgical Innovations, Inc. 10460 Bubb Road Cupertino, CA 95014 (408) 863-2531 863-1100 (fax)
Date Summary Prepared : August 8, 1997 2.

Trade Name(s): 3.

Spacemaker® Surgical Balloon Dissector with and without Cannula Spacemaker® II Surgical Balloon Dissector with and without Cannula Spacemaker® Serial Surgical Balloon Dissector w/ or w/o Cannula & w/ or w/o Visualization

4. Common Name

Surgical Balloon Dissector

5. Predicate devices

K926010 Surgical Dissector with Cannula K944418 Spacemaker® and Spacemaker II Surgical Balloon Dissector and Cannula K951878 Spacemaker® and Spacemaker® II Surgical Balloon Dissector with and without a Canmila, Class II K952278 Reusable Spacemaker® Surgical Balloon Dissector with Cannula K962702 Spacemaker® Serial Surgical Balloon Dissector with or without Cannula and with or without Visualization K953377 Tapered Tip Balloon Dissection Cannula K935426 Preperitoneal Distention Balloon System K946002 Longitudinal Dissection Balloon System K954174 Duo Balloon System (1and 2) K964171 Vasos View Balloon Dissection System Device Description 6. The Spacemaker® Surgical Balloon Dissector devices are handheld, manually manipulated

surgical balloon dissectors. The devices can be supplied with either a solid center rod or a hollow center rod. The hollow center rod allows for the insertion of an endoscopic visualization accessory, if desired. The devices can be supplied with or without a cannula. The cannula

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provides access for operative and diagnostic instrumentation for the surgical procedure.

This submission seeks to gain clearance for the Spacemaker® Surgical Balloon Dissectors with all of the specific indications for use that have been delineated in previous submissions.

7. Intended Use

The device is indicated for any area of the body where it is necessary to separate the layers of connective tissue for surgical access. The intended use of the Spacemaker® Surgical Balloon Dissectors is to create an operative space by dissecting layers of connective tissue along natural tissue planes of separation of the extraperitoneal (including preperitoneal and retroperitoneal), or subcutaneous extremity or thoracic space.

The indications for use include dissection of tissue for the following surgical procedures: endoscopic; laparoscopic; general surgery; plastic and reconstructive surgery, including aesthetic surgery, vascular surgery for the exposure of superficial vessels of the upper and/or lower extremities (no deep structure would be targeted), including the saphenous vein and femoral vessels; thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall; procedures in the extraperitoneal space involving dissection of tissue lavers allowing exposure of structures including: adrenals, bone, spine, lymph nodes, and kidneys.

Examples of specific surgical procedures the Spacemaker® Surgical Balloon Dissectors may be used to facilitate tissue dissection include: fascial layers between the skin and peritoneum, hernia repair, varicocele dissection, sympathectomy, lymph node dissection, urethropexy, subfascial perforator vein ligation, access to the saphenous vein and femoral vessels, retroperitoneal access to the anterior spine, access for long bone plating.

The cannula portion of the device is intended to provide access for surgical and diagnostic instruments for the duration of the operative procedure.

8. Comparison to Predicate Devices

Substantial equivalence is based on the fact that all of the Spacemaker® Surgical Balloon Dissectors have the same principle of operation as the predicate devices (there are no changes to any of the Spacemaker® devices). There are no new indications for use. All of the indications for

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use have been included in one or more of the predicate device submissions and including these indications for use in all of the Spacemaker® Surgical Balloon Dissectors labeling does not raise different questions regarding safety or efficacy or have any impact on safety and efficacy of the Spacemaker® Surgical Balloon Dissectors compared to the predicate devices. Therefore, it can be concluded that the Spacemaker® Surgical Balloon Dissectors with the inclusion of the indications for use (from the predicate devices) are substantially equivalent to the predicate devices.

Testing in Support of Substantial Equivalence Determination 9.

No functional bench testing was performed for this submission because no tests were necessary to substantiate the safety, performance or substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with stylized wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 16 1998

Ms. Cathleen Mantor Regulatory Affairs/Ouality Assurance Manager General Surgical Innovations 10460 Bubb Road Cupertino, California 95014

Re: K973046

Trade Name: Spacemaker® Surgical Balloon Dissector, Spacemaker® II Surgical Balloon Dissector Regulatory Class: II Product Code: GCJ Dated: October 31, 1997 Received: November 5, 1997

Dear Ms. Mantor:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices oan be found in the Code of Federal Regulations, Title 21: " Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification

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Page 2 - Ms. Mantor

submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use 8.1

510(k) Number (If Known): 973046

Device Name:

The cannula portion of the device is intended to provide access for surgical and diagnostic. ..... - - -- --instruments for the duration of the operative procedure.

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

5
(Division Sion Off)
Dive General Restorative Devices
510(k) Number K973046

Regulation Number and Section

§ 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.