(17 days)
Not Found
No
The document describes a mechanical surgical device (trocar and balloon dissector) and makes no mention of AI or ML capabilities.
No
The device facilitates surgical procedures by providing access and separating tissue, but it does not directly treat a disease or condition.
No
The device description and intended use state that it is used to provide a port of access and tissue separation during laparoscopic surgery, and for insertion of endoscopic instruments. These are surgical tools, not devices used for diagnosis.
No
The device description explicitly states it consists of a balloon dissector and trocar, which are physical hardware components used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device used during surgical procedures to create access ports and separate tissue within the body (abdominal cavity or extraperitoneal space). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description reinforces its use in conjunction with laparoscopic surgery for access and tissue separation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue samples, etc.) outside of the body to provide information about a patient's health, diagnose conditions, or monitor treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with tissues during surgery.
N/A
Intended Use / Indications for Use
The Modified SPACEMAKER* System:
SPACEMAKER* Structural Balloon Trocar
The SPACEMAKER* Structural Balloon Trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.
SPACEMAKER* Blunt Tip Trocar
The SPACEMAKER* Blunt Tip Trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
SPACEMAKER* Dissection Balloon
The SPACEMAKER* Dissection Balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
Product codes
GCJ
Device Description
The Modified SPACEMAKER* System consists of a balloon dissector and trocar which are used in conjunction to provide a port of access and tissue separation during laparoscopic surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity or extraperitoneal space
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Auto Suture* Dissection Balloon, Auto Suture* Blunt Tip Trocar, Auto Suture* Structural Balloon Trocar
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
Attachment 4
SEP 2 4 2004
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510(k) Summary
Modified SPACEMAKER* System
United States Surgical 150 Glover Avenue Norwalk, CT 06856 USA
DEVICE DESCRIPTION
The Modified SPACEMAKER* System consists of a balloon dissector and trocar which are used in conjunction to provide a port of access and tissue separation during laparoscopic surgery.
CLASSIFICATION NAME
Balloon Dissectors/ Balloon Trocars
INDICATIONS FOR USE
SPACEMAKER* Structural Balloon Trocar
The SPACEMAKER * Structural Balloon Trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.
SPACEMAKER* Blunt Tip Trocar
The SPACEMAKER* Blunt Tip Trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
SPACEMAKER* Dissection Balloon
The SPACEMAKER* Dissection Balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
MATERIALS:
All material components of the Modified SPACEMAKER* System comply with ISO Standard #10993-1.
PREDICATE DEVICES
Auto Suture* Dissection Balloon Auto Suture* Blunt Tip Trocar Auto Suture* Structural Balloon Trocar
Special 510(k) August 31, 2004 *Trademark
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2004
Ms. Reneé Alfano Associate, Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856
Re: K042412
Trade/Device Name: Modified SPACEMAKER System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: September 2, 2004 Received: September 7, 2004
Dear Ms. Alfano:
:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave determined and marketed predicate devices marketed in interstate for use stated in the encrosule) to regars actment date of the Medical Device Art on the closed Force commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costlience Act (Act) that to not require to the general controls provisions of the Act. The 1 ou may, mercere, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 as controls. Existing major regulations affecting your device can inay be subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may be found in the over ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Drivesan that your device complies with other requirements of the Act that I DA has made a acterialized administered by other Federal agencies. You must of any I cacal statutes and registements, including, but not limited to: registration and listing (21 Comply with an the Fee Brequirements, while and manufacturing practice requirements as set CI K Fat 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in the qualis) 350cc provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Reneé Alfano
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will unow your o begin mailing of substantial equivalence of your device to a legally premailted predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific as noliance at (301) 594-4659. Also, please note the regulation entitled, Connot the Office of Court Court Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
Indications for Use Statement
Device Name
Modified SPACEMAKER* System
Indications For Use
The Modified SPACEMAKER* System:
SPACEMAKER* Structural Balloon Trocar
The SPACEMAKER* Structural Balloon Trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.
SPACEMAKER* Blunt Tip Trocar
The SPACEMAKER* Blunt Tip Trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
SPACEMAKER* Dissection Balloon
The SPACEMAKER* Dissection Balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
(Please do not write below this line - continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use: | |
| (Per 21 CFR 801.109) | ✓ |
| OR Over-The-Counter Use: |
Miriam C. Provat
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Special 510 (k)
August 31, 2004
| *Trademark | Attachment 2.1 |
|---|---|
| 510(k) Number | K042412 |