(168 days)
Not Found
No
The device description focuses on mechanical components (obturator, cannula, seals, valves, balloon, bolster) and their physical function. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No.
The device provides a port of entry and stabilization for surgical instruments, but it does not directly treat a disease or condition itself.
No
Explanation: The device, a SoftFix™ Balloon Trocar, is described as providing a port of entry for endoscopic instruments and for maintaining pneumoperitoneum during surgical procedures. Its function is to facilitate access and stability for other instruments, not to diagnose conditions.
No
The device description clearly details physical components such as an obturator, cannula, seal system, inflatable balloon, movable bolster, stopcock, and inflation port. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a port of entry for endoscopic instruments into the body cavity of patients." This describes a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a surgical instrument (trocar) used to create an opening and maintain access during endoscopic procedures. It focuses on mechanical features for insertion, stabilization, and maintaining pneumoperitoneum.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
The device is clearly a surgical instrument used in vivo (within the body) during a medical procedure.
N/A
Intended Use / Indications for Use
The SoftFixTM Balloon Trocar have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments into the body cavity of patients.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The SoftFix™ Balloon Trocar is a series of sterile and single-use Trocar intended to be included as an extension to the previously cleared Unimax Trocar Series.
In general, the Trocars from Unimax Trocar Series consist of an Obturator and a Cannula containing a seal system. The Obturator is used to place the cannula through the incision site into the patient's body cavity where the Cannula remains anchored at a desired position. For that anchoring purpose, previously cleared Trocars belonging to the Unimax Trocar Series are equipped with threaded Cannulas or Cannulas with a movable bolster. As a series extension, the Cannulas belonging to the SoftFix™ Balloon Trocars are now available with an inflatable balloon and a manually movable bolster to provide stabilization and minimize the fascial trauma during an endoscopic procedure. Whereas these Cannulas are also designed to be compatible with the Obturators belonging to the previously cleared Trocars from the Unimax Trocar Series. The balloon and movable bolster combination on the cannula come with two options;
- a) "SoftFix™ Balloon Fixation Ring" combination
- b) "SoftFix™ Balloon Fixation Cone" combination
Similar to Cannulas of the Trocars from the Unimax Trocar Series, each Cannula of the SoftFix™ Balloon Trocars is a combination of a sleeve and a housing, fitted with a pair of seal and valve to maintain pneumoperitoneum when the Obturator or other laparoscopic devices are inserted or withdrawn through it during the surgical procedures. The Cannula also contains a stopcock with rotation valve at its proximal end in order to allow or prevent passage of any insufflation gas (e.g. CO2), when needed. Near the stopcock, the Cannula contains an inflation port to inflate/deflate the balloon using a standard syringe. While the movable "fixation ring" can be slid down the Cannula sleeve to adjust its height as well as fixing the Cannula at a desired position, the height of the "fixation cone" can be adjusted by pressing the thumb notch present on it and the Cannula can be anchored at the desired position by affixing fascial sutures on the struts present near the thumb notch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body 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)
Non-clinical testing was conducted including Biocompatibility (In vitro Cytotoxicity test as per ISO 10993-5, Irritation test per ISO 10993-10, Skin sensitization test per ISO 10993-10), Sterility (Sterilization Validation per ISO 11135, Sterile Packaging per ISO 11607-1), and Bench Performance Testing (Obturator Insertion Test, Obturator Removal Test, Trocar Penetration Test, Cannula Stabilization Test, Air-Leakage Test, Balloon Volume Test, Balloon Rigidity Test, Fixation Device Retention Test). All tests passed their respective acceptance criteria, demonstrating that design and performance requirements were met and establishing substantial equivalence to predicate devices.
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.
Not Found
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/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
November 5, 2021
Unimax Medical Systems Inc. Monoi Mon Kalita, Ph.D. Senior Regulatory Affairs Specialist 8F-2, No.127, Ln.235, Pao Chiao Rd., Xindian District, New Taipei City 231. Taiwan
Re: K211577
Trade/Device Name: SoftFix Balloon Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 15, 2021 Received: September 20, 2021
Dear Dr. Kalita:
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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211577
Device Name SoftFixTM Balloon Trocar
Indications for Use (Describe)
The SoftFixTM Balloon Trocar have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments into the body cavity of patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for UNIMAX. The logo consists of an orange diamond shape with a white square inside of it, followed by the word "UNIMAX" in gray letters. The logo is simple and modern.
510(k) Summary K211577
Image /page/3/Picture/3 description: The image shows an orange logo of a woodpecker pecking at a triangle. The triangle is also orange and has two white dots on it. The woodpecker is facing right and has a long beak. The logo is simple and modern.
The following information are provided according to the requirements as per 21 CFR 807.92.
SPONSOR/APPLICANT INFORMATION 1.1.
| Sponsor/Applicant | Sponsor Contact Information | Date Prepared |
|---|---|---|
| Unimax Medical Systems Inc. | ||
| 8F-2, No.127, Ln.235, Pao Chiao Rd., | ||
| Xindian Dist., New Taipei City | ||
| 231,Taiwan | Monoj Mon Kalita, Ph.D. | |
| Senior Regulatory Affairs Specialist | ||
| Ph: +886-2-8919-1698 ext. 202 | ||
| Fax: +886-2-8919-1528 | ||
| Email: mon@unimaxmeds.com | 2021/11/04 |
SUBJECT DEVICE INFORMATION 1.2.
| Device Trade Name | : | SoftFix™ Balloon Trocar |
|---|---|---|
| Classification Name | : | Laparoscope, General & Plastic Surgery |
| Regulation Number | : | 21 CFR 876.1500 |
| Regulatory Class | : | Class II |
| Product Code | : | GCJ |
| Regulation Description | : | Endoscope and accessories |
| Review Panel | : | General & Plastic Surgery |
| 510(k) Number | : | K211577 |
PREDICATE DEVICE INFORMATION 1.3.
| Item | Description |
|---|---|
| Device Name | GelPort® Blunt Tip Trocar System |
| 510(k) Number | K060629 |
| Manufacturer | Applied Medical Resources Corporation |
| 22872 Avenida Empresa | |
| Rancho Santa Margarita, CA-92688 | |
| Item | Description |
| Device Name | Fixation Trocars |
| 510(k) Number | K083638 |
4
Image /page/4/Picture/1 description: The image shows the logo for Unimax. The logo consists of an orange diamond shape with a white square inside of it, followed by the word "UNIMAX" in gray. The diamond shape is on the left side of the logo, and the word "UNIMAX" is on the right side.
510(k) Summary K211577
Image /page/4/Picture/3 description: The image is a logo with an orange background. On the right side of the image, there is a bird with a long beak. The bird is facing left and appears to be pecking at a white line that is going through a triangle shape on the left side of the image.
DEVICE DESCRIPTION 1.4.
The SoftFix™ Balloon Trocar is a series of sterile and single-use Trocar intended to be included as an extension to the previously cleared Unimax Trocar Series.
In general, the Trocars from Unimax Trocar Series consist of an Obturator and a Cannula containing a seal system. The Obturator is used to place the cannula through the incision site into the patient's body cavity where the Cannula remains anchored at a desired position. For that anchoring purpose, previously cleared Trocars belonging to the Unimax Trocar Series are equipped with threaded Cannulas or Cannulas with a movable bolster. As a series extension, the Cannulas belonging to the SoftFix™ Balloon Trocars are now available with an inflatable balloon and a manually movable bolster to provide stabilization and minimize the fascial trauma during an endoscopic procedure. Whereas these Cannulas are also designed to be compatible with the Obturators belonging to the previously cleared Trocars from the Unimax Trocar Series. The balloon and movable bolster combination on the cannula come with two options;
- a) "SoftFix™ Balloon Fixation Ring" combination
- b) "SoftFix™ Balloon Fixation Cone" combination
Similar to Cannulas of the Trocars from the Unimax Trocar Series, each Cannula of the SoftFix™ Balloon Trocars is a combination of a sleeve and a housing, fitted with a pair of seal and valve to maintain pneumoperitoneum when the Obturator or other laparoscopic devices are inserted or withdrawn through it during the surgical procedures. The Cannula also contains a stopcock with rotation valve at its proximal end in order to allow or prevent passage of any insufflation gas (e.g. CO2), when needed. Near the stopcock, the Cannula contains an inflation port to inflate/deflate the balloon using a standard syringe. While the movable "fixation ring" can be slid down the Cannula sleeve to adjust its height as well as fixing the Cannula at a desired position, the height of the "fixation cone" can be adjusted by pressing the thumb notch present on it and the Cannula can be anchored at the desired position by affixing fascial sutures on the struts present near the thumb notch.
| Attribute | GelPort® Blunt Tip
Trocar System
(Predicate Device) | Fixation Trocars
(Predicate
Device) | SoftFix™
Balloon Trocar
(Subject Device) | Equivalence/
Difference
Determination | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K060629 | K083638 | K211577 | NA | |
| Classification
Name | Laparoscope, General &
Plastic Surgery | Laparoscope, General
& Plastic Surgery | Laparoscope, General
& Plastic Surgery | Equivalent | |
| Manufacturer | Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, CA-92688 | | Unimax Medical
Systems Inc.
8F-2, No. 127, Lane
235, Pao Chiao Road,
Xindian District, New
Taipei City, Taiwan | NA | |
| Class | II | II | II | Equivalent | |
| Product Code | GCJ | GCJ | GCJ | Equivalent | |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Equivalent | |
| Intended Use | The GelPort Blunt Tip
Trocar System is indicated
for use in general,
abdominal, gynecological
and thoracic minimally
invasive surgical
procedures to establish a | The Fixation Trocar
is a sterile, single-use
device, intended for
use in conjunction
with APPLIED's
currently marketed
trocar products to | The SoftFix™
Balloon Trocar have
application in a
variety of endoscopic
procedures to provide
a port of entry for
endoscopic | Equivalent | |
| Attribute | GelPort® Blunt Tip
Trocar System
(Predicate Device) | Fixation Trocars
(Predicate
Device) | SoftFix TM
Balloon Trocar
(Subject Device) | Equivalence/
Difference
Determination | |
| | path of entry or to gain
access through tissue
planes, extraperitoneal
spaces and/or potential
spaces for endoscopic
instruments. | establish a path of
entry for endoscopic
instruments for use
during general,
abdominal,
gynecological and
thoracic minimally
invasive procedures
or to gain access
through tissue planes
and/or potential
spaces for endoscopic
instruments. The
Fixation Trocar may
be used with an
optical tissue
separator or a bladed
obturator, and with or
without visualization
for primary and
secondary insertions. | instruments into the
body cavity of
patients. | | |
| Obturators | Optical Obturator | • Optical Obturator
• Optical Obturator
with insufflation
port
• Bladed Obturator
with safety lock for
the shield | • Bladed Obturator
with safety lock for
the shield
• Bladeless Obturator
• Optical Obturator
• Hasson Obturator | Different,
Difference in
available
obturators does
not affect the
substantial
equivalence of the
subject device. | |
| Cannula | • Housing with a seal to
prevent air-leakage
• Housing with safety lock
for the obturator
• Cannula Sleeve with a
stopcock for insufflation | • Housing with a seal
to prevent air-
leakage
• Housing with safety
lock for the
obturator
• Cannula Sleeve
with a stopcock for
insufflation | • Housing with a seal
to prevent air-
leakage
• Housing with safety
lock for the
obturator
• Cannula Sleeve with
a stopcock for
insufflation | Equivalent | |
| | • Balloon - Fixation Cone
combination on the
Cannula | • Balloon - Fixation
Ring combination
on the Cannula | • Balloon - Fixation
Ring combination
on the Cannula
• Balloon – Fixation
Cone combination
on the Cannula | Equivalent | |
| Cannula
Fixation
Mechanism | Suture Tie on Fixation
Cone | - | Suture Tie on
Fixation Cone | Similar
Suture tie is
provided only
with the 'Fixation
Cone' model. This
difference is only
due to different
design aspect and
does not alter | |
| Attribute | GelPort® Blunt Tip
Trocar System
(Predicate Device) | Fixation Trocars
(Predicate Device) | SoftFixTM
Balloon Trocar
(Subject Device) | Equivalence/
Difference
Determination | |
| | Non-latex balloon
Balloon inflation port on
the cannula | Non-latex balloon
Balloon inflation port
on the cannula | Non-latex balloon
Balloon inflation port
on the cannula | Equivalent | |
| | | | | Equivalent | |
| Cannula Dimension | Diameter | 5.0 - 12.0 mm | 5.0 - 15.0 mm | 5.0 - 12.0 mm | Similar
The Trocars are
available in a
range of
diameters. This
variation in
diameter is only to
allow entry of
other endoscopic
instruments and
does not have any
effect on device
performance.
Additionally,
diameter
information is
printed on the
Cannula housing. |
| | | | | | |
| | Length | 100.0 - 130.0 mm | 55.0 - 150.0 mm | 70.0 - 100.0 mm | Similar
Similar to the
rational above, the
Trocars are
available in a
range of length.
Choice of Trocar
length depends on
user's preference. |
| | | | | | |
| | Sterilization | Sterilized using irradiation | Sterilized using
irradiation | Sterilized using EtO | Different,
Difference in
sterilization
method does not
affect the safety
and effectiveness
of the subject
device as it is
sterilized by using
a validated
sterilization
method identical
to the previously
cleared Unimax
Trocar Series. |
| | | | | | |
| | Operating
Principle | Penetrates the thick tissue
layers while providing a
port of entry for the | Penetrates the thick
tissue layers while
providing a port of | Penetrates the thick
tissue layers while
providing a port of | Equivalent |
| | | endoscopic instruments into | entry for the | entry for the | |
| Attribute | GelPort® Blunt Tip
Trocar System
(Predicate Device) | Fixation Trocars
(Predicate
Device) | SoftFix TM
Balloon Trocar
(Subject Device) | Equivalence/
Difference
Determination | |
| | the body cavity. The
balloon fixation mechanism
helps to anchor the Cannula
at a desired position and
reduces its migration. | endoscopic
instruments into the
body cavity. The
fixation mechanism
helps to anchor the
Cannula at a desired
position and reduces
its migration. | endoscopic
instruments into the
body cavity. The
fixation mechanism
helps to anchor the
Cannula at a desired
position and reduces
its migration. | | |
PREDICATE COMPARISON 1.5.
5
Image /page/5/Picture/0 description: The image contains the word "UNIMAX" in gray font. To the left of the word is an orange diamond shape with a white square inside. The diamond is oriented so that one of its points is facing upwards.
510(k) Summary
Image /page/5/Picture/3 description: The image shows an orange logo with a woodpecker holding a branch in its beak. The woodpecker is positioned on the right side of the logo, facing left. To the left of the woodpecker is an orange triangle with two white dots on it. The logo is simple and eye-catching.
6
Image /page/6/Picture/0 description: The image contains the logo for Unimax. The logo consists of an orange diamond shape with a white square inside of it. To the right of the diamond is the word "UNIMAX" in gray sans-serif font.
510(k) Summary K211577
Image /page/6/Picture/3 description: The image shows an orange logo with a woodpecker. The woodpecker is on the right side of the logo, and it is facing left. The woodpecker is pecking at a triangle on the left side of the logo. There are two white dots on the triangle.
7
Image /page/7/Picture/0 description: The image contains the logo for UNIMAX. The logo consists of an orange diamond shape with a white square inside of it, followed by the text "UNIMAX" in gray. The diamond shape is located to the left of the text.
510(k) Summary K211577
Image /page/7/Picture/3 description: The image shows an orange logo with a woodpecker. The woodpecker is facing right and is pecking at a triangular shape. The triangular shape has two white dots on it and a white line going through the middle.
1.6. NON-CLINICAL PERFORMANCE TESTING
The following non-clinical testing were conducted to demonstrate that the design and performance requirements were met as well as to determine the substantial equivalence of the subject devices with the predicate devices.
| Attribute | Test Method | Acceptance Criteria | Result
(PASS/FAIL) |
|---------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Biocompatibility | In vitro Cytotoxicity test as per ISO 10993-5 | Test article shall be non-cytotoxic | PASS |
| | Irritation test per ISO 10993-10 | Test article shall not induce any significant irritation. | PASS |
| | Skin sensitization test per ISO 10993-10 | Test article shall not induce any significant sensitization | PASS |
| Sterility | Sterilization Validation per ISO 11135 | The sterilization method shall be validated | PASS |
| | Sterile Packaging per ISO 11607-1 | The device packaging shall remain sterile during its shelf life period | PASS |
| Bench
Performance
Testing | Obturator Insertion Test | Obturators of the devices shall have an insertion force lower than the predefined threshold value when inserted through the cannula. | PASS |
| | Obturator Removal Test | Obturators of the devices shall have a removal force lower than the predefined threshold value when removed from the cannula. | PASS |
| | Trocar Penetration Test | The Trocars shall have an insertion force lower than the predefined threshold value when inserted through layers of skin with varying thickness. | PASS |
| | Cannula Stabilization Test | The Cannulas shall remain stable at its original position after maneuver of instruments with varying sizes. | PASS |
| | Air-Leakage Test | The Trocars shall not have any leakage and shall be able to maintain a constant value during real use simulation. | PASS |
| | Balloon Volume Test | The balloons on the Trocars shall be inflated to the recommended volume and shall maintain the predefined threshold diameter. | PASS |
| | Balloon Rigidity Test | The balloons on the Trocars shall withstand the predefined threshold value when mechanically pulled with a constant force. | PASS |
| | Fixation Device
Retention Test | The fixation device shall withstand the predefined threshold value when mechanically pushed with a constant force. | PASS |
8
Image /page/8/Picture/1 description: The image shows the logo for Unimax. The logo consists of an orange diamond shape with a white square inside of it, followed by the word "UNIMAX" in gray. The word "UNIMAX" is written in a sans-serif font.
510(k) Summary K211577
Image /page/8/Picture/3 description: The image is an orange logo on a white background. The logo features a triangle with two dots inside, and a bird pecking at the triangle. The bird is facing right and has a long beak. The logo is simple and modern.
1.7. CONCLUSION
The SoftFix™ Balloon Trocar has identical intended use with predicate devices as they act as port of entry for the endoscopic instruments into the patient body cavity. In addition to this, the devices incorporate similar Obturators into the Cannulas.
In conclusion, the abovementioned regulatory, technical as well as non-clinical testing summaries demonstrate that the SoftFix™ Balloon Trocar is as safe, as effective and perform as equivalent to the predicate devices and hence are found to be substantially equivalent.