(29 days)
No
The device description and performance studies focus on mechanical and functional aspects of surgical access and dissection tools, with no mention of AI/ML or data processing.
Yes
The device is described as a "dissection balloon" and "structural balloon trocar" used in laparoscopic surgical procedures for "tissue separation," "tissue retraction," and establishing "a sealed port of access." These are direct interventions on the body for therapeutic purposes (surgery).
No
The device is described as a "dissection balloon" and "blunt tip trocar" intended for surgical procedures requiring tissue separation, port access, and tissue retraction. Its purpose is to facilitate surgery, not to diagnose a condition.
No
The device description clearly outlines physical components like balloons, trocars, and optical ports, and the performance studies involve physical testing of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery for tissue separation, access, and retraction within the body (extraperitoneal space and abdominal cavity). This is a surgical device, not a device used to examine specimens outside the body to diagnose conditions.
- Device Description: The description details surgical tools like dissection balloons, trocars, and optical ports, all designed for use within a surgical setting.
- Performance Studies: The performance studies focus on the physical and functional performance of the device during surgical procedures (e.g., inflation/deflation force, seal leak resistance, insertion/withdrawal force, dissection clarity). These are not studies related to diagnostic accuracy or the analysis of biological samples.
IVD devices are used to examine specimens such as blood, urine, or tissue in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Spacemaker™ Pro system does not fit this description.
N/A
Intended Use / Indications for Use
The Spacemaker™ Pro dissection balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
The Spacemaker™ Pro 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.
The Spacemaker™ Pro 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Spacemaker™ Pro access and dissector system consists of combinations of three dissectors and two balloon access devices integrated into a single, modular device. There are a total of five Spacemaker™ Pro device combinations. Blunt tip trocar with round dissection balloon Blunt tip trocar with oval dissection balloon Blunt tip trocar with cylindrical dissection balloon Structural balloon trocar with round dissection balloon Structural balloon trocar with oval dissection balloon Each combination also includes two 5mm optical ports cleared under K112349, for use during the laparoscopic procedure, and also includes an Obturator accessory in a shorter length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extraperitoneal space, abdominal cavity
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)
Performance studies (in vitro and in vivo) were conducted to demonstrate that the proposed device, is substantially equivalent to the predicate device.
In vitro testing that supports the intended use of this device includes:
- Visual Inspection
- Stopcock Insufflation/Desufflation
- Balloon Inflation Force and Deflation Force using Syringe
- Balloon Inflation and Deflation Force using a Bulb
- Seal Leak Resistance
- Instrument Insertion and Withdrawal Force for Seal System
- Pressure to Inflate Dissector Balloon
- Dissector Balloon Leak Test
- Dissector Obturator Insertion and Withdrawal Force into/from Dissector
- Dissector balloon insertion force into cannula and withdrawal force
- Obturator Insertion and Withdrawal Force into/from Cannula
- 10mm Laparoscope Insertion and Withdrawal Force into/from Cannula
- Dissector Balloon Acuity
- 5mm Laparoscope Insertion and Withdrawal from Dissector
- Dissector Balloon Integrity
- Cannula Balloon Integrity
- Dissector Balloon Deflation
- Oval Dissector's Perforated Sheath
- Blunt Tip Trocar Balloon Diameter Measurement
In vivo testing that supports the intended use of the device includes:
- Dissection/Dissector Clarity
- Dissector Balloon Integrity
- Force Required to Remove Dissector
- Cannula Leak Functional Performance
- Balloon Functional Performance
- Trocar Balloon Removal/Anchoring Force
The results of testing demonstrate that the modified Spacemaker™ Pro Access and Dissector System is substantially equivalent to the legally marketed Spacemaker™ Plus System(K042412).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2015
Covidien LLC Ms. Rebecca Magnanimo Regulatory Affairs Product Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K151356
Trade/Device Name: Spacemaker™ Pro Access and Dissector System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: May 18, 2015 Received: May 20, 2015
Dear Ms. Magnanimo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name SpacemakerTM Pro Access and Dissector System
Indications for Use (Describe)
The Spacemaker™ Pro dissection balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
The Spacemaker™ Pro 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.
The Spacemaker™ Pro 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Page 31 of 117
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510(k) Summary
| SUBMITTER: | Covidien IIc
60 Middletown Avenue
North Haven, CT 06473 USA |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Rebecca Magnanimo
Regulatory Affairs Product Specialist
Covidien IIc
Phone: (203) 492-6479
Fax: (203) 492-5029
e-mail: Rebecca.magnanimo@covidien.com |
| DATE PREPARED: | 05/18/15 |
| PRODUCT CODE: | GCJ |
| REGULATION NUMBER: | 21 CFR 876.1500 |
| TRADE/PROPRIETARY NAME: | Spacemaker™ Pro Access and Dissector System |
| COMMON/USUAL NAME: | Access Dissection System |
| CLASSIFICATION NAME: | Endoscope and Accessories |
| PREDICATE DEVICES: | Spacemaker™ System (K042412) |
| DEVICE DESCRIPTION: | The Spacemaker™ Pro access and dissector system consists of
combinations of three dissectors and two balloon access devices
integrated into a single, modular device. There are a total of five
Spacemaker™ Pro device combinations. Blunt tip trocar with round dissection balloon Blunt tip trocar with oval dissection balloon Blunt tip trocar with cylindrical dissection balloon Structural balloon trocar with round dissection balloon Structural balloon trocar with oval dissection balloon Each combination also includes two 5mm optical ports cleared
under K112349, for use during the laparoscopic procedure, and
also includes an Obturator accessory in a shorter length. |
| INTENDED USE | The Spacemaker™ Pro dissection balloon is primarily indicated
for patients undergoing laparoscopic surgery requiring tissue
separation of the extraperitoneal space.
The Spacemaker™ Pro 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.
The Spacemaker™ Pro structural balloon trocar is primarily
indicated for patients undergoing laparoscopic surgical
procedures requiring a sealed port of access and/or tissue
Page 33 of 117 |
4
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.
SUMMARY COMPARING THE TECHNOLOGICAL CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICES:
Modifications to design and materials of the current Spacemaker™ Plus Line (K042412) have created five new product codes to be launched as the proposed Spacemaker™ Pro Access and Dissection System.
The changes include use of alternate material to remove latex from fixation/anchoring balloons (blunt tip trocar products), increase length of cannulas/dissection cannulas, addition of a stopcock, changes to balloon geometry (length and width), addition of 5mm reducer to allow for device use with 5mm instruments and addition of a shorter length obturator previously sold separately.
Also a new cylindrical shaped balloon design will be offered to facilitate component separation by including a new cylindrical shaped design to the dissection balloon.
The proposed Spacemaker Pro will also include two 5mm Trocar ports (K112349).
The proposed Spacemaker Pro was evaluated for the following:
- Biocompatibility studies were conducted for the proposed device.
- . Sterilization has been evaluated.
- . Stability studies for the proposed device have been performed.
- . Performance studies (in vitro and in vivo) were conducted to demonstrate that the proposed device, is substantially equivalent to the predicate device.
In vitro testing that supports the intended use of this device includes:
In vitro Testing:
- Visual Inspection ■
- I Stopcock Insufflation/Desufflation
- 트 Balloon Inflation Force and Deflation Force using Syringe
- l Balloon Inflation and Deflation Force using a Bulb
- I Seal Leak Resistance
- 트 Instrument Insertion and Withdrawal Force for Seal System
- . Pressure to Inflate Dissector Balloon
- . Dissector Balloon Leak Test
- 트 Dissector Obturator Insertion and Withdrawal Force into/from Dissector
5
- " Dissector balloon insertion force into cannula and withdrawal force
- י Obturator Insertion and Withdrawal Force into/from Cannula
- 10mm Laparoscope Insertion and Withdrawal Force into/from Cannula
- . Dissector Balloon Acuity
- 트 5mm Laparoscope Insertion and Withdrawal from Dissector
- " Dissector Balloon Integrity
- l Cannula Balloon Integrity
- 트 Dissector Balloon Deflation
- . Oval Dissector's Perforated Sheath
- . Blunt Tip Trocar Balloon Diameter Measurement In-vivo testing that supports the intended use of the device includes:
In vivo Testing:
- Dissection/Dissector Clarity '
- I Dissector Balloon Integrity
- " Force Required to Remove Dissector
- " Cannula Leak Functional Performance
- . Balloon Functional Performance
- Trocar Balloon Removal/Anchoring Force
The results of testing demonstrate that the modified Spacemaker™ Pro Access and Dissector System is substantially equivalent to the legally marketed Spacemaker™ Plus System(K042412).
CONCLUSION: