(31 days)
Not Found
No
The device description and performance studies focus on mechanical function and manual operation, with no mention of AI or ML.
No
The device is used for tissue separation during laparoscopic surgery and does not perform a therapeutic function to treat a disease or condition.
No
The device is described as a "Dissecting Balloon System" used for tissue separation during laparoscopic surgery, not for diagnosing medical conditions. Its function is to create space for surgical procedures, as evidenced by "Tissue separation" and "dissection" in the text, and it's stated as being applied to "patients undergoing laparoscopic surgery".
No
The device description clearly outlines physical components (rigid cannula, inflatable balloon, introducer, dissecting cannula, inflation bulb) and their mechanical functions, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Dissecting Balloon System is a surgical tool used during a laparoscopic procedure to physically separate tissue planes. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly states it's for "patients undergoing laparoscopic surgery requiring tissue separation." This describes a surgical intervention, not a diagnostic test.
The device is a surgical instrument used in vivo (within the body) during a procedure, not an in vitro diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Dissecting Balloon System is indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Applied Medical's Dissecting Balloon System consists of a rigid cannula with an inflatable balloon attached at the distal end that achieves separation of tissue planes during laparoscopic surgery. The system is provided sterile.
The system includes three main components: An introducer that facilitates insertion of the balloon through an abdominal incision. A dissecting cannula with attached balloon, which is compatible with a 10mm endoscope to allow for visualization during tissue separation. Two balloon configurations will be offered (oval and round). An inflation bulb that is used to manually inflate the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility: The biocompatibility evaluation for Applied Medical's Dissecting Balloon System was conducted in accordance with the FDA's guidance document. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The subject device contacts tissue for a duration of less than 24 hours, so the following endpoints were considered and all materials were found to be biocompatible: Cytotoxicity, Intracutaneous Irritation, Sensitization, Acute Systemic Toxicity.
Functional Performance: Side-by-side bench top testing was performed with the subject and predicate device systems to demonstrate substantial equivalence. The bench top tests were designed to focus on the functional performance of a blunt dissection balloon device. Both subject and predicate device systems were evaluated for: Device insertion, Tissue separation, Surgical site visualization, Balloon deflation and device removal.
Results of testing demonstrate that the subject Dissecting Balloon System is substantially equivalent to the predicate Preperitoneal Distention Balloon System, and that the subject device performs comparably to the current marketed device for the same intended use.
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.
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August 30, 2018
Applied Medical Resources Corp. Corinne Yestrepsky Regulatory Affairs Specialist II 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K182024
Trade/Device Name: Dissecting Balloon System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: July 27, 2018 Received: July 30, 2018
Dear Corinne Yestrepsky:
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. 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/ofdocs/ofpmn.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.
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
1
devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical on-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, 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
Indications for Use
510(k) Number (if known)
Device Name Dissecting Balloon System
Indications for Use (Describe)
The Dissecting Balloon System is indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
| 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) |
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510(k) Summary
| 510(K) Submitter: | Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Corinne Yestrepsky, PhD
Regulatory Affairs Specialist II
Applied Medical Resources Corp.
corinne.yestrepsky@appliedmedical.com
Tel: (949) 713-8176
Fax: (949) 713-8205 |
| Date of Preparation: | July 27, 2018 |
| Trade Name: | Dissecting Balloon System |
| Common Name: | Blunt Dissection Balloon |
| Classification: | Regulation: 21 CFR 876.1500, Endoscope & Accessories
Device Class: Class II
Product Code: GCJ |
| Predicate Device: | Preperitoneal Distention Balloon System
510(k)#: K935426
Product Code: GCJ |
| Device Description: | Applied Medical's Dissecting Balloon System consists of a rigid
cannula with an inflatable balloon attached at the distal end that
achieves separation of tissue planes during laparoscopic surgery.
The system is provided sterile.
The system includes three main components:
An introducer that facilitates insertion of the balloon through an abdominal incision. A dissecting cannula with attached balloon, which is compatible with a 10mm endoscope to allow for visualization during tissue separation. Two balloon configurations will be offered (oval and round). An inflation bulb that is used to manually inflate the balloon |
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The Dissecting Balloon System is indicated for patients Indications for use: undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.
Comparison of Technological Characteristics with the Predicate Device
The subject and predicate device systems are both blunt dissection balloons intended to separate tissue planes in the extraperitoneal space. Both systems contain an introducer, dissecting cannula with attached balloon, and inflation bulb. The subject and predicate systems are both offered in two balloon configurations (oval and round). Furthermore, each system is compatible with a 10mm endoscope to facilitate visualization of tissue separation.
The subject device system differs from the predicate in that the subject round balloon is encased in a perforated sheath to facilitate insertion where the predicate round balloon is not. Both the predicate and subject oval balloons are encased in a sheath.
Discussion of Performance Testing
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation for Applied Medical's Dissecting Balloon System was conducted in accordance with the FDA's guidance document. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The subject device contacts tissue for a duration of less than 24 hours, so the following endpoints were considered and all materials were found to be biocompatible.
- Cytotoxicity
- Intracutaneous Irritation
- Sensitization
- Acute Systemic Toxicity
Functional Performance
Side-by-side bench top testing was performed with the subject and predicate device systems to demonstrate substantial equivalence. The bench top tests were designed to focus on the functional performance of a blunt dissection balloon device. Both subject and predicate device systems were evaluated for:
- . Device insertion
- Tissue separation ●
- . Surgical site visualization
- Balloon deflation and device removal ●
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Conclusion
Results of testing demonstrate that the subject Dissecting Balloon System is substantially equivalent to the predicate Preperitoneal Distention Balloon System, and that the subject device performs comparably to the current marketed device for the same intended use.