(162 days)
Not Found
No
The device description and intended use clearly describe a manually manipulated surgical balloon device with no mention of AI or ML capabilities.
No.
The device's intended use is to create surgical space and expand tissue for reconstruction and correction of deformities, which is a surgical tool rather than a therapeutic treatment for disease or condition.
No
This device is described as a surgical balloon dissector and expander used for creating surgical spaces and tissue expansion, which are therapeutic/interventional functions, not diagnostic.
No
The device description clearly states it is a "handheld, manually manipulated surgical balloon device" with physical components like a balloon dissector and injection port/connector, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create a surgical space anywhere in the body by dissecting layers of connective tissue... and provide intraoperative and subsequent tissue expansion." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "handheld, manually manipulated surgical balloon device which dissects tissue planes, intraoperatively and subsequently expands the overlying tissue." This description aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, 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 mechanical and surgical.
N/A
Intended Use / 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.
Product codes
FZW, LCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anywhere in the body
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K951878, K904265, K862203, K843704
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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):
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
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.