The intended use of the Spacemaker® Surgical Balloon Dissector/Expander is to create a surgical space anywhere in the body by dissecting layers of connective tissue along natural planes of separation and provide intraoperative and subsequent tissue expansion. The Spacemaker® Surgical Balloon Dissector/Expander is a temporary subcutaneous or submuscular implant device. The indications for use include the following: breast reconstruction, limb reconstruction, correction of congenital deformities and cosmetic defects, and scar revision.

Device Description

The Spacemaker® Surgical Balloon Dissector/Expander device is a handheld, manually manipulated surgical balloon device which dissects tissue planes, intraoperatively and subsequently expands the overlying tissue. This device is a temporary subcutaneous or submuscular implant device. The Spacemaker® Surgical Balloon Dissector/Expander is a single use, disposable device provided sterile to the physician. The major components of the device are a balloon dissector and an injection port/connector.

AI/ML Overview

This document is a 510(k) summary for the Spacemaker® Surgical Balloon Dissector/Expander, a medical device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner you're requesting for an AI/ML device.

Here's why and what information is provided:

This device is a Class I manually operated surgical instrument for general use, which was cleared in 1997. At that time, and for this type of device, the regulatory pathway (510(k)) primarily focused on demonstrating substantial equivalence to legally marketed predicate devices, not on proving performance against specific acceptance criteria through extensive clinical studies as would be required for higher-risk or AI/ML devices today.

The document states:

"Testing in Support of Substantial Equivalence: Specific ASTM tests relating to the design differences between the Spacemaker® Surgical Balloon Dissector/Expander and the predicate devices were performed to evaluate if the differences would raise new questions of safety or efficacy. The results of this testing indicated no new issues were raised."

This indicates that some design-related tests were performed (likely mechanical or material tests according to ASTM standards), but these are not performance studies in the context of diagnostic accuracy, which is what your questions imply for AI/ML.

Therefore, I cannot provide:

A table of acceptance criteria and the reported device performance: This information is not present in the document. The clearance was based on substantial equivalence to existing devices.
Sample size used for the test set and the data provenance: Not applicable in the context of an "AI/ML" test set. The "tests" mentioned were likely engineering/device performance tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML device designed for diagnostic interpretation.
If a standalone performance study was done: "Specific ASTM tests" were done to evaluate design differences, but not a standalone clinical performance study as would be expected for an AI/ML diagnostic tool. The clearance is based on equivalence.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable (this is not an AI/ML device).
How the ground truth for the training set was established: Not applicable (this is not an AI/ML device).

Summary of available relevant information from the document:

Device Name: Spacemaker® Surgical Balloon Dissector/Expander
Regulatory Pathway: 510(k) (Substantial Equivalence)
Principle of Operation: Handheld, manually manipulated surgical balloon device which dissects tissue planes and expands overlying tissue.
Tests Performed: "Specific ASTM tests relating to the design differences between the Spacemaker® Surgical Balloon Dissector/Expander and the predicate devices were performed to evaluate if the differences would raise new questions of safety or efficacy. The results of this testing indicated no new issues were raised."
Basis for Clearance: Substantial equivalence to predicate devices (K951878 Spacemaker® and Spacemaker® II, K904265 Inamed Ruiz-Cohen Intraoperative Expander, K862203 McGhan Magna-Site™ Tissue Expander, K843704 McGhan Tissue Expander).

The document is a regulatory clearance for a physical surgical tool from 1997, preceding the widespread use of AI/ML in medical devices and the associated regulatory requirements for performance metrics and studies.

Summary

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10/13/2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

General Surgical Innovations Cathleen Mantor Regulatory Affairs/ Quality Assurance Manager 10460 Bubb Rd. Cupertino, California 95014

Re: K972109

Trade/Device Name: Spacemaker® Surgical Balloon Dissector/expander Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: FZW

Dear Cathleen Mantor:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 14, 1997. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code FZW.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Deborah Fellhauer, OHT4: Office of Surgical and Infection Control Devices, 301-796-9570, Deborah.Fellhauer@fda.hhs.gov.

Sincerely,

Deborah A. Fellhauer - S Deborah A. Fellhauer -S 2022.10.13 13:13:29 -04'00'

Deborah A. Fellhauer RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized image of a human figure in profile, with three overlapping figures suggesting a sense of community or support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

NOV 1 4 1997

K972109 Re:

Trade Name: Spacemaker® Surgical Balloon Dissector/Expander Regulatory Class: Unclassified Product Code: LCJ Dated: September 26, 1997 Received: September 29, 1997

Dear Ms. Mantor:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can 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. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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.

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Page 2 - Ms. Cathleen Mantor

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

If you desire specific advice for your device 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 device, 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 vours.

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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8.1 Statement of Indications for Use

510(k) Number (if known):

K972109

Device Name

Spacemaker® Surgical Balloon Dissector/Expander

Indications for Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-the-Counter Use
(per 21 CFR 801.109)			(Optional format 2Jan96)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K972109
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K972109

510(k) Summary

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).

1.Contact Person

Cathleen Mantor RA/QA Manager General Surgical Innovations, Inc. 10460 Bubb Road Cupertino, CA 95014

(408)863-2531 (408)863-1000 - Fax

2.Date Summary Prepared

6/4/97

3.Trade Name

Spacemaker® Surgical Balloon Dissector/Expander

4.Common Name

Surgical Balloon Dissector/Expander

5.Predicate Devices

K951878	Spacemaker® and Spacemaker® II Surgical Balloon Dissector with andwithout Cannula
K904265	Inamed Ruiz-Cohen Intraoperative Expander
K862203	McGhan Magna-Site™ Tissue Expander
K843704	McGhan Tissue Expander

6.Device Description

The Spacemaker® Surgical Balloon Dissector/Expander device is a handheld,

manually manipulated surgical balloon device which dissects tissue planes,

intraoperatively and subsequently expands the overlying tissue. This device is a

temporary subcutaneous or submuscular implant device. The Spacemaker® Surgical

Balloon Dissector/Expander is a single use, disposable device provided sterile to the

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physician. The major components of the device are a balloon dissector and an injection port/connector.

7.Intended Use

8.Comparison to Predicate Devices

The claim of substantial equivalence is based on the fact that the GSI Spacemaker® Surgical Balloon Dissector/Expander has the same principle of operation and intended uses as the predicate device. These differences do not raise additional questions regarding safety or efficacy compared to the predicate devices. Therefore, it can be concluded that the Spacemaker® Surgical Balloon Dissector/Expander is substantially equivalent to the predicate devices.

The following table lists the similarities and differences between the Spacemaker® Surgical Balloon Dissector/Expander and predicate devices.

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DEVICEPOINT OFCOMPARISON		INAMED RUIZ-COHENINTRAOPERATIVETISSUE EXPANDER(K904265)	MCGHAN MAGNA-SITE™ TISSUEEXPANDER (K862203)	MCGHAN TISSUEEXPANDER (K843704)	SPACEMAKER®SURGICAL BALLOONDISSECTOR/ TISSUEEXPANDER
Intended Use	SPACEMAKER® &SPACEMAKER®IIDISSECTOR WITH &W/OUT CANNULA(K951878)	Intraoperative tissueexpansion	Tissue expansion	Tissue expansion	Dissect layers ofconnective tissue alongnatural planes ofseparation & provideintraoperative &subsequent tissueexpansion
Indications	Dissect layers ofconnective tissuealong natural planes ofseparation	Where rapid creationof a tissue flap isneeded in a singlesurgical session forscar revision or otherskin defects	Post mastectomyreconstruction,augmentation and scarrevision	Post mastectomyreconstruction,augmentation and scarrevision	Breast reconstruction,limb reconstruction,correction of congenitaldeformities andcosmetic defects, andscar revision
Examples of Under-lying ProceduresAssociated withSurgical Dissection(Expansion) Specifiedin the Labeling	Any area of the bodywhere it is necessaryto separate the layersof connective tissuefor surgical access	Unknown	Unknown	Unknown	General, laparoscopic,endoscopic, plastic andreconstructive,including aesthetic,surgery
How Supplied	General, laparoscopic,endoscopic, plasticand reconstructive,including aesthetic,surgery	Unknown	Single use	Single use	Single patient use,disposable
Principle of Operation	Single patient use,disposable	Handheld, manuallymanipulated tissueexpander	Handheld, manuallymanipulated tissueexpander	Handheld, manuallymanipulated tissueexpander	Handheld, manuallymanipulated surgicaldissector/expander
Balloon VolumeRange	Handheld, manuallymanipulated surgicaldissector10-2500cc saline or airinflation	0.8-40cc saline (fromcatalog andInstructions for Use)	50-800cc	Range of sizes (andshapes)	1-2500cc saline or airinflation
Balloon Shapes	Include kidney, clover,horseshoe, semi-roundand U-shaped profiles	Cylindrical andspherical (fromcatalog)	Round and rectangular	Range of (sizes and)shapes	Range of (sizes and)shapes
Balloon Function	Balloon dissector	Balloon expander	Balloon expander	Balloon expander	Balloondissector/expander
Balloon Cover	Yes	No	No	No	Optional
Filling	Not applicable	Not applicable	Injection port and connector	Injection port and connector	Injection port and connector
Communication forTemporary Implant	Not applicable	Not applicable	Palpation and magnetic	Palpation	Palpation
Port Detection Method	Not applicable	Intraoperative, single surgical session	Temporary implantation; typically less than 90 days	Temporary implantation; less than 60 days	Temporary implantation; typically less than 90 days
Materials	Polymers, silicone and stainless steel	Silicone, polymers	Silicone, stainless steel	Silicone, stainless steel	Polymers, silicone and stainless steel
PackagingConfiguration	With or without cannula	With blunt needle or stopcock	With or without injection port and connector	With or without injection port and connector	Without cannula, with or without injection port and connector

4June97

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Testing in Support of Substantial Equivalence: 9.

Specific ASTM tests relating to the design differences between the Spacemaker® Surgical Balloon Dissector/Expander and the predicate devices were performed to evaluate if the differences would raise new questions of safety or efficacy. The results of this testing indicated no new issues were raised.

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.