(50 days)
Not Found
No
The device description and performance testing focus on mechanical properties and biocompatibility, with no mention of AI or ML.
Yes
The device is described as facilitating the passage of endoscopes and instruments for the treatment of urinary stones or other urinary diseases, and it is used for the removal of foreign bodies in the urinary tract, which are all therapeutic actions.
No
The device is an access sheath designed to facilitate the passage of endoscopes and other instruments into the urinary tract for treatment purposes (e.g., removing urinary stones or foreign bodies), not to diagnose conditions.
No
The device description clearly outlines physical components such as a sheath, dilator, Y connector, and mentions materials like thermoplastic elastomer and stainless-steel coil. It also describes physical characteristics like dimensions and hydrophilic coating. There is no mention of software as part of the device itself.
Based on the provided text, the Dornier Hoover Negative Pressure Access Sheath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to establish a conduit during endoscopic urological procedures to facilitate the passage of instruments and treat urinary stones or other urinary diseases. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical device used for accessing the urinary tract and potentially collecting specimens during a procedure. It's a tool for intervention and access, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the living organism) to provide diagnostic information. There's no mention of reagents, assays, or any form of laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Dornier Hoover Negative Pressure Access Sheath is a surgical access and procedural device.
N/A
Intended Use / Indications for Use
The Dornier Hoover Negative Pressure Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
FED, FAJ, FGA
Device Description
The Dornier Hoover Negative Pressure Access Sheath is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. It is for the passage of endoscopes and other urological devices for Ureteroscopy and used for the treatment of stones and for the removal of foreign bodies in the urinary tract.
The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic- coated guide sheath with joint.
The guide sheath is fitted with a Y connector on the Y connector is bifurcated straight tube and oblique tube. One segment of the Y connector is straight and is contiguous with the sheath. The other is constructed in an oblique angle with a longitudinal pressure control vent. The oblique tube is to be connected to a negative pressure aspirator with clear tube or alternatively, connected to a specimen collector then onto a negative pressure aspirator, then to collect stones or foreign bodies during the endoscopic procedure.
A dilator is included for the insertion of the dilator is radiopaque and is fitted with a hand buckle on the proximal end. The dilator can be locked to the proximal end of the straight tube using a locking mechanism.
The Dornier Hoover Negative Pressure Access Sheath is reinforced with a stainless-steel coil, constructed of a medical grade thermoplastic elastomer. All colorants used are compliant with FDA standards.
The device is offered of inner diameter in French size 10Fr, 12Fr and length 40cm, 50cm. The device is supplied sterile and intended for single use only.
The Dornier Hoover Neqative Pressure Access Sheath has six different models. The structural composition and materials of the different models are identical. The only difference is in dimension including inner diameter, and length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary tract
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 bench testing was conducted to verify that the performance of the Dornier Hoover Negative Pressure Access Sheath is substantially equivalent to the predicate device, and that the device will perform as intended.
General performance testing including:
Connection Strengths
Coefficients of Friction
Dimensional Analysis
Fluid Leakage
Testing data and results are included in this submission and demonstrate that the Dornier Hoover Negative Pressure Access Sheath meets all the pre-determined testing and acceptance criteria.
The following Biocompatibility testing was performed:
Cytotoxicity as per ISO 10993-5:2009
Irritation as per ISO 10993-23:2021
Sensitization as per ISO 10993-10:2021
Biocompatibility testing reports are included in this submistrate that the device components that are in contact with the patient are biocompatible.
Sterilization by ethylene oxide has been validated for Dornier Hoover Negative Pressure Access Sheath in accordance with ENISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
The nonclinical performance bench testing of the device demonstrates the Pressure Access Sheath meets its design requirements. The testing also subject device is substantially equivalent in these characteristics to the predicate device.
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
January 31, 2025
Dornier MedTech America John Hoffer Vice President Ouality Assurance and Regulatory Affairs 1155 Roberts Blvd Suite 100 Kennesaw, Georgia 30144
Re: K243820
Trade/Device Name: Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED, FAJ, FGA Received: December 12, 2024
Dear John Hoffer:
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.
1
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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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
2
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,
Mark R. Kreitz -S
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040. IVX-NS-1050. IVX-NS-1140. IVX-NS-1150. IVX-NS-1240. IVX-NS-1250)
Indications for Use (Describe)
The Dornier Hoover Negative Pressure Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic 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)
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| K243820 | |||
|---|---|---|---|
| 510(k) #: | 510(k) Summary | Page 1 of 3 Prepared on: 2024-12-12 | |
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Dornier MedTech America | ||
| Applicant Address | 1155 Roberts blvd Suite 100 Kennesaw ga 30144 United States | ||
| Applicant Contact Telephone | 770-514-6163 | ||
| Applicant Contact | Mr. John Hoffer | ||
| Applicant Contact Email | jhoffer@dornier.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250) | ||
| Common Name | Endoscopic Access Overtube, Gastroenterology-Urology | ||
| Classification Name | Endoscope and Accessories | ||
| Regulation Number | 21 CFR § 876.1500 | ||
| Product Code(s) | FED, FAJ,FGA | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K161110 | ClearPetra Ureteral Access Sheath | FED | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
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K243820
The Dornier Hoover Negative Pressure Access Sheath is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. It is for the passage of endoscopes and other urological devices for Ureteroscopy and used for the treatment of stones and for the removal of foreign bodies in the urinary tract.
The packaged product includes a Hydrophilic-coated Dilator with a locking mechanism and a Hydrophilic- coated guide sheath with joint.
The guide sheath is fitted with a Y connector on the Y connector is bifurcated straight tube and oblique tube. One segment of the Y connector is straight and is contiguous with the sheath. The other is constructed in an oblique angle with a longitudinal pressure control vent. The oblique tube is to be connected to a negative pressure aspirator with clear tube or alternatively, connected to a specimen collector then onto a negative pressure aspirator, then to collect stones or foreign bodies during the endoscopic procedure.
A dilator is included for the insertion of the dilator is radiopaque and is fitted with a hand buckle on the proximal end. The dilator can be locked to the proximal end of the straight tube using a locking mechanism.
The Dornier Hoover Neqative Pressure Access Sheath is reinforced with a stainless-steel coil, constructed of a medical grade thermoplastic elastomer. All colorants used are compliant with FDA standards.
The device is offered of inner diameter in French size 10Fr, 12Fr and length 40cm, 50cm. The device is supplied sterile and intended for single use only.
The Dornier Hoover Neqative Pressure Access Sheath has six different models. The structural composition and materials of the different models are identical. The only difference is in dimension including inner diameter, and length.
| Model | Length(mm) | Inner diameter | Outer diameter |
|---|---|---|---|
| IVX-NS-1040 | 400 | 3.30(10Fr) | 3.96(12Fr) |
| IVX-NS-1050 | 500 | 3.30(10Fr) | 3.96(12Fr) |
| IVX-NS-1140 | 400 | 3.66(11Fr) | 4.32(13Fr) |
| IVX-NS-1150 | 500 | 3.66(11Fr) | 4.32(13Fr) |
| IVX-NS-1240 | 400 | 3.96(12Fr) | 4.62(14Fr) |
| IVX-NS-1250 | 500 | 3.96(12Fr) | 4.62(14Fr) |
Intended Use/Indications for Use
The Dornier Hoover Negative Pressure Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Indications for Use Comparison
The predicate device and the device subject to this submission have the same indications for use.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
6
The Dornier Hoover Negative Pressure Access Sheath has essentially the same technological characteristics as the predicate device. Both devices are comparable in their material composition, their mechanical characteristics and their use. As noted above, the indication for use are the same for both devices are both single use and are sterilized with ETO. Based on the results from the comparative testing as described in the attachment, although there are in characteristics between the subject and predicate products are substantially equivalent.
The predicate device has not been subject to a design-related recall.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following performance bench testing was conducted to verify that the performance of the Dornier Hoover Negative Pressure Access Sheath is substantially equivalent to the predicate device, and that the device will perform as intended.
General performance testing including: Connection Strengths Coefficients of Friction Dimensional Analysis Fluid Leakage
Testing data and results are included in this submission and demonstrate that the Dornier Hoover Negative Pressure Access Sheath meets all the pre-determined testing and acceptance criteria.
The following Biocompatibility testing was performed: Cytotoxicity as per ISO 10993-5:2009 Irritation as per ISO 10993-23:2021 Sensitization as per ISO 10993-10:2021
Biocompatibility testing reports are included in this submistrate that the device components that are in contact with the patient are biocompatible.
Sterilization by ethylene oxide has been validated for Dornier Hoover Negative Pressure Access Sheath in accordance with ENISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
The nonclinical performance bench testing of the device demonstrates the Pressure Access Sheath meets its design requirements. The testing also subject device is substantially equivalent in these characteristics to the predicate device.
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