Spacemaker Pro Access and Dissector System by Covidien LLC

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Spacemaker™ Pro Access and Dissector System." It details the device, its intended use, and compares it to a predicate device. The document lists various in vitro and in vivo tests conducted to demonstrate substantial equivalence, but it does not explicitly state specific acceptance criteria or report device performance details for these tests. It generally concludes that "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)."

Therefore, I cannot provide a table of acceptance criteria and reported device performance as that specific information is not present in the provided text. I also cannot fulfill requests for sample sizes, data provenance, expert details, or multi-reader studies as these are not mentioned.

However, I can extract information related to the types of studies conducted:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in the provided text.
Reported Device Performance: Not explicitly detailed in the provided text, beyond the general conclusion of substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable as no expert-established ground truth is mentioned for the testing described. The studies appear to be performance-based engineering and functional tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC or AI-related studies are mentioned. This device is a medical instrument, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No standalone algorithm performance is mentioned, as this is a physical medical device. The "in vitro" and "in vivo" performance studies described can be considered standalone performance for the device itself.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For the performance studies listed, the "ground truth" would be established by objective measurements and observations of the device's physical and functional characteristics against predetermined engineering specifications and safety standards, rather than expert consensus on diagnostic images or pathology. For example, for "Balloon Inflation Force" or "Dissector Balloon Leak Test," the ground truth is a pass/fail against a quantifiable threshold.

8. The sample size for the training set:

Not applicable, as this is a physical medical device, not a machine learning algorithm.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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

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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

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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)

K151356

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.

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FORM FDA 3881 (8/14)

Page 1 of 1

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Page 31 of 117

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510(k) Summary

SUBMITTER:	Covidien IIc60 Middletown AvenueNorth Haven, CT 06473 USA
CONTACT PERSON:	Rebecca MagnanimoRegulatory Affairs Product SpecialistCovidien IIcPhone: (203) 492-6479Fax: (203) 492-5029e-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 ofcombinations of three dissectors and two balloon access devicesintegrated into a single, modular device. There are a total of fiveSpacemaker™ 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 clearedunder K112349, for use during the laparoscopic procedure, andalso includes an Obturator accessory in a shorter length.
INTENDED USE	The Spacemaker™ Pro dissection balloon is primarily indicatedfor patients undergoing laparoscopic surgery requiring tissueseparation of the extraperitoneal space.The Spacemaker™ Pro blunt tip trocar is intended for use inestablishing a port of access for insertion of endoscopicinstruments into the abdominal cavity or extraperitoneal space inabdominal and extraperitoneal surgery.The Spacemaker™ Pro structural balloon trocar is primarilyindicated for patients undergoing laparoscopic surgicalprocedures requiring a sealed port of access and/or tissuePage 33 of 117

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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

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" 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:

Regulation Number and Section

§ 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.