Who is the manufacturer of SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER?

General Surgical Innovations filed the 510(k) submission for SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (K972109).

What is the FDA product code for SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER?

FZW. It is classified under 21 CFR 878.4800 as a Class 1 device in the General, Plastic Surgery panel.

What is the regulatory pathway for SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER?

Spacemaker® and Spacemaker® II Surgical Balloon Dissector with and without Cannula (K951878); Inamed Ruiz-Cohen Intraoperative Expander (K904265); McGhan Magna-Site™ Tissue Expander (K862203); McGhan Tissue Expander (K843704).

Who can help prepare an FDA 510(k) submission like SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER

K972109 · General Surgical Innovations · FZW · Nov 14, 1997 · General, Plastic Surgery

Device Facts

Record ID	K972109
Device Name	SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER
Applicant	General Surgical Innovations
Product Code	FZW · General, Plastic Surgery
Decision Date	Nov 14, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4800
Device Class	Class 1
Attributes	Therapeutic

Intended Use

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 Story

Handheld, manually manipulated surgical balloon device; used for tissue dissection along natural planes and tissue expansion. Input: saline or air for inflation (1-2500cc). Operation: physician inserts balloon subcutaneously or submuscularly; inflates to dissect tissue or expand; injection port/connector allows controlled inflation. Used in general, laparoscopic, endoscopic, plastic, and reconstructive surgeries. Output: physical creation of surgical space or expanded tissue volume. Benefits: facilitates surgical access and tissue expansion for reconstructive procedures. Single-use, disposable, provided sterile.

Clinical Evidence

Bench testing only. Specific ASTM tests performed to evaluate design differences compared to predicates; results indicated no new safety or efficacy issues.

Technological Characteristics

Materials: polymers, silicone, stainless steel. Principle: manual balloon dissection/expansion. Energy: manual inflation (saline/air). Form factor: handheld balloon with injection port/connector. Sterilization: provided sterile. Connectivity: none.

Indications for Use

Indicated for patients requiring breast reconstruction, limb reconstruction, correction of congenital deformities, cosmetic defects, or scar revision. Used for creating surgical space via tissue dissection and for intraoperative/subsequent tissue expansion.

Regulatory Classification

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.

Predicate Devices

Spacemaker® and Spacemaker® II Surgical Balloon Dissector with and without Cannula (K951878)
Inamed Ruiz-Cohen Intraoperative Expander (K904265)
McGhan Magna-Site™ Tissue Expander (K862203)
McGhan Tissue Expander (K843704)

Related Devices

K962702 — SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, WITH VISUALIZATION AND WITH VISUALIZATION AND CANNULA · General Surgical Innovations · Feb 19, 1997
K973046 — SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAL BALLOON DISSECTOR, SAPHTRAK · General Surgical Innovations · Jan 16, 1998
K984448 — BIRCOLL BALLOON DISSECTOR · Wells Johnson Co. · Jan 28, 1999
K182024 — Dissecting Balloon System · Applied Medical Resources Corp. · Aug 30, 2018
K983792 — SEARE BIOMEDICAL SILICONE TISSUE EXPANDER · Seare Biomedical Corp. · Dec 11, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ 8.1 Statement of Indications for Use 510(k) Number (if known): K972109 ## Device Name Spacemaker® Surgical Balloon Dissector/Expander # Indications for Use 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. 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 | |---------------|---------| |---------------|---------| - . {4}------------------------------------------------ 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 and without 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 {5}------------------------------------------------ physician. The major components of the device are a balloon dissector and an injection port/connector. # 7.Intended Use 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. # 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. {6}------------------------------------------------ | DEVICE POINT OF COMPARISON | | INAMED RUIZ- COHEN INTRAOPERATIVE TISSUE EXPANDER (K904265) | MCGHAN MAGNA- SITE™ TISSUE EXPANDER (K862203) | MCGHAN TISSUE EXPANDER (K843704) | SPACEMAKER® SURGICAL BALLOON DISSECTOR/ TISSUE EXPANDER | |------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | SPACEMAKER® & SPACEMAKER®II DISSECTOR WITH & W/OUT CANNULA (K951878) | Intraoperative tissue expansion | Tissue expansion | Tissue expansion | Dissect layers of connective tissue along natural planes of separation & provide intraoperative & subsequent tissue expansion | | Indications | Dissect layers of connective tissue along natural planes of separation | Where rapid creation of a tissue flap is needed in a single surgical session for scar revision or other skin defects | Post mastectomy reconstruction, augmentation and scar revision | Post mastectomy reconstruction, augmentation and scar revision | Breast reconstruction, limb reconstruction, correction of congenital deformities and cosmetic defects, and scar revision | | Examples of Under- lying Procedures Associated with Surgical Dissection (Expansion) Specified in the Labeling | Any area of the body where it is necessary to separate the layers of connective tissue for surgical access | Unknown | Unknown | Unknown | General, laparoscopic, endoscopic, plastic and reconstructive, including aesthetic, surgery | | How Supplied | General, laparoscopic, endoscopic, plastic and reconstructive, including aesthetic, surgery | Unknown | Single use | Single use | Single patient use, disposable | | Principle of Operation | Single patient use, disposable | Handheld, manually manipulated tissue expander | Handheld, manually manipulated tissue expander | Handheld, manually manipulated tissue expander | Handheld, manually manipulated surgical dissector/expander | | Balloon Volume Range | Handheld, manually manipulated surgical dissector 10-2500cc saline or air inflation | 0.8-40cc saline (from catalog and Instructions for Use) | 50-800cc | Range of sizes (and shapes) | 1-2500cc saline or air inflation | | Balloon Shapes | Include kidney, clover, horseshoe, semi-round and U-shaped profiles | Cylindrical and spherical (from catalog) | Round and rectangular | Range of (sizes and) shapes | Range of (sizes and) shapes | | Balloon Function | Balloon dissector | Balloon expander | Balloon expander | Balloon expander | Balloon dissector/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 for Temporary 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 | | Packaging Configuration | 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 {7}------------------------------------------------ . : {8}------------------------------------------------ #### 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.