(88 days)
Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.
Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.
The system is composed of four main components:
- An obturator that facilitates insertion of the system through an incision.
- A cannula with bolster and attached balloon, encased within a perforated sheath.
- A seal which maintains insufflation.
- An inflation bulb that is used to manually inflate and deflate the balloon.
N/A
FDA 510(k) Clearance Letter - Kii Structural Balloon Access System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
October 31, 2025
Applied Medical Resources Corp.
Derek Greene
Regulatory Affairs Associate Principal Specialist
22872 Avenida Empresa
Rancho Santa Margarita, California 92688
Re: K252442
Trade/Device Name: Kii Structural Balloon Access System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: August 1, 2025
Received: August 4, 2025
Dear Derek Greene:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.
Page 2
October 31, 2025
Applied Medical Resources Corp.
Derek Greene
Regulatory Affairs Associate Principal Specialist
22872 Avenida Empresa
Rancho Santa Margarita, California 92688
Re: K252442
Trade/Device Name: Kii Structural Balloon Access System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: August 1, 2025
Received: August 4, 2025
Dear Derek Greene:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.
K252442 - Derek Greene Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K252442 - Derek Greene Page 3
assistance/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,
Colin Kejing Chen
Acting 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
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Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252442 |
|---|---|
| Please provide the device trade name(s). | |
| Kii Structural Balloon Access System |
| Please provide your Indications for Use below. |
|---|
| Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space. |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
Kii Structural Balloon Access System Page 10 of 81
Page 5
510(k) Summary
510(k) #: K252442
Contact Details
| Applicant Name | Applied Medical Resources Corp. |
|---|---|
| Applicant Address | 22872 Avenida Empresa Rancho Santa Margarita CA 92688 United States |
| Applicant Contact Tel. | 949-713-8009 |
| Applicant Contact | Dr. Derek Greene |
| Applicant Contact Email | derek.greene@appliedmedical.com |
| Preparation Date | 30 October 2025 |
Device Name
| Device Trade Name | Kii Structural Balloon Access System |
|---|---|
| Common Name | Endoscope and accessories |
| Classification Name | Laparoscope, General & Plastic Surgery |
| Regulation Name | 876.1500 |
| Product Code(s) | GCJ |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name | Product Code |
|---|---|---|
| K942636 | Auto Suture Structural Balloon Trocar | GCJ |
| K060096 | Modular Trocar System (reference device) | GCJ |
| K182024 | Dissecting Balloon System (reference device) | GCJ |
Device Description Summary
Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.
The system is composed of four main components:
- An obturator that facilitates insertion of the system through an incision.
- A cannula with bolster and attached balloon, encased within a perforated sheath.
- A seal which maintains insufflation.
- An inflation bulb that is used to manually inflate and deflate the balloon.
Page 6
510(k) Summary
Intended Use/Indications for Use
Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.
Indications for Use Comparison
The indications for use of the subject and predicate device systems contain minor differences, which do not change the intended use of the device. Both contain an indication for the same essential function of the device to allow the passage of laparoscopic instrumentation through the device, with the subject referring to this as a "path of entry" and the predicate referring to this as a "sealed port of access". The predicate device includes indications for patients undergoing laparoscopic surgical procedures, as well as patients undergoing laparoscopic surgery in extraperitoneal procedures. The subject device utilizes a subset of those indications, only referencing to patients undergoing laparoscopic surgery of the extraperitoneal space. The indications of the predicate device list specific procedural examples that may take place within the extraperitoneal space. The indications of the subject device do not explicitly list example procedures, however it can be used within those outlined in the indications of the predicate device.
Technological Comparison
The subject and predicate device systems are both structural balloon trocars intended to provide access as a port of entry for laparoscopic instrumentation and retract tissue in the extraperitoneal space. Both systems contain an obturator and cannula. Both obturators have a blunt tip to aid in insertion of the device. Both cannulas contain a bolster mechanism, which inhibits trocar migration and seals for insufflation, and balloon inflation port that is compatible with an inflation bulb. Both cannulas contain an "A-frame" balloon that is encased within a perforated sheath that opens and remains anchored to the cannula as the balloon is inflated with the inflation bulb. Both systems contain a seal mechanism, which interfaces with insufflation tubing and maintains insufflation with and without instruments inserted.
Page 7
510(k) Summary
The subject device system has minor differences from the predicate device. The seal mechanism of the subject device is detachable, while the predicate device is affixed to the cannula. The materials and components of the seal and bolster of the subject device are different from the predicate; however, they perform the same core function. Lastly, the inflation bulb to be used with the subject device is provided separately (as part of the Kii Dissecting Balloon, cleared within K182024), whereas it is provided within the same packaging of the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions
Non-clinical tests:
The following performance data is provided in support of the substantial equivalence determination:
Biocompatibility
The biocompatibility evaluation for the Brand X device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,'" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices − Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The structural balloon device is considered tissue contacting for a duration of less than 24 hours, therefore the following testing was performed:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Pyrogen Testing
Functional Performance
Testing was conducted to verify that the subject device met all design specifications and performed equivalent to the predicate device. Benchtop testing assessed functional performance of the structural balloon device and included the following:
- Simulated Use Tests
- Balloon Dimensional Comparison
- Bolster Leak Test
Page 8
510(k) Summary
- Balloon Burst Test
Sterility
Testing was conducted to validate the sterilization of the device to a SAL of 10^-6. Testing was conducted in compliance with: ANSI AAMI ISO 13004: 2022, ANSI AAMI ISO 11137: 2006/(R)2015, ISO 11137-2 Third edition 2013-06 [Including AMD1:2022], ANSI AAMI ISO 11137-3: 2017(R)2023, ISO 11737-1 Third edition 2018-01 [Including AMD1:2021], and ANSI AAMI ISO 11737-2: 2019
Shelf-Life
Testing was performed to qualify the subject device for a 36-month shelf life. Testing was conducted in compliance with: ASTM F1980;2021, ASTM F88/F88M-15;2023, and ASTM F1929;2023.
Clinical tests:
Not Applicable. Clinical data were not required to support the safety or effectiveness of the subject device.
Conclusion:
The results of the testing demonstrated that the subject Kii Structural Balloon Access System is substantially equivalent to the currently marketed predicate Auto Suture Structural Balloon Trocar for the same intended use. The non-clinical testing is sufficient evidence for the safety and efficacy of the subject device for its indications for use.
§ 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.