(308 days)
No
The device description and performance studies focus on the mechanical aspects of cell collection and do not mention any computational analysis or interpretation of data using AI/ML.
No
The device is indicated for the collection and retrieval of surface cells for diagnostic purposes (cytology), not for treating a disease or condition.
No
This device is for the collection of cells (specimen collection), which are then to be analyzed for diagnostic purposes. The device itself does not perform the diagnosis.
No
The device description clearly outlines physical components like a catheter, silicone balloon, collection pleats, and cytology collection strips, indicating it is a hardware device.
Based on the provided information, the Strome-Blitzer Cytology Balloon device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the "collection and retrieval of surface cells from the esophagus." These collected cells are then used for "cytologic examination" to produce "diagnostically useful cytology samples."
- Device Description: The device is designed to collect biological specimens (cells) for analysis.
- Performance Studies: The animal study describes "cytologic examination of esophageal smears" and the generation of "diagnostically useful cytology samples." This strongly indicates that the collected material is intended for in vitro analysis to aid in diagnosis.
- Predicate Device: The predicate device, the Brandt Esophageal Cytology Balloon, is also a device used for collecting cells for cytology, which is an in vitro diagnostic technique.
- Reference Device: The reference device, the US Endoscopy Cytology Brush, is another device used for collecting cells for cytology.
IVD devices are defined as those intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or for the assessment of health. The Strome-Blitzer Cytology Balloon fits this description because it collects specimens (esophageal cells) that are then examined (cytologically) to provide information that can be used for diagnostic purposes.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and the nature of the collected material and its subsequent analysis strongly align with the definition of an IVD.
N/A
Intended Use / Indications for Use
The Strome-Blitzer Cytology Balloon device is indicated for use in the 4-quadrant collection and retrieval of surface cells from the esophagus in adults (22 years of age or older). The device may be delivered transorally under direct endoscopic visualization.
Product codes (comma separated list FDA assigned to the subject device)
EOX, FDX, BTR
Device Description
The Strome-Blitzer Cytology Balloon is an inflatable biopsy platform. It consists of a catheter with a silicone balloon at its distal end. The balloon has 6 collection pleats on its surface. Inside each pleat are 2 cytology collection strips for specimen collection. While the balloon is uninflated, the strips are covered by the balloon pleats. When inflated, the strips are exposed. The balloon inflates and deflates with the use of a syringe and attached catheter, and is a sterile, single-use device. There are 4 location indicator dots on the proximal balloon surface for orientation during esophagoscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
Indicated Patient Age Range
adults (22 years of age or older)
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)
Dimensional and Functional Performance Testing (Bench)
This included:
- Cytology collection strip inspection
- Balloon bond joint inspection
- Distal atraumatic tip inspection
- Device trackability and balloon to shaft joint integrity test
- Device total length
- Balloon length
- Catheter shaft internal diameter
- Catheter shaft outer diameter
- Maximum balloon profile (deflated)
- Axial orientation indicator dot inspection
- Balloon inflation-deflation cycle test
- Device kink resistance to evaluate balloon's ability to contain strips during device insertion and removal
- Balloon pressure evaluation and burst test
- Shaft to Luer joint tensile strength
- Shaft to balloon joint tensile strength
Animal Study of Safety and Effectiveness
Study Type: Animal Study
Sample Size: Six swine
Key Results: There were no procedure-related complications. Cytologic examination of esophageal smears prepared with the Strome-Blitzer Cytology Balloon resulted in diagnostically useful cytology samples of high cellularity that were morphologically comparable to those generated with the reference cytology brush. Cytology collection procedures were well tolerated by the animals, with no inflammatory response or edema in the tissue of the distal esophagus in control or test areas.
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.
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
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 13, 2019
ADN International LLC % Eric Bannon Regulatory Consultant AlvaMed, Inc. 935 Great Plain Avenue, #166 Needham, MA 02492
Re: K182159
Trade/Device Name: Strome-Blitzer Cytology Balloon Regulation Number: 21 CFR§ 874.4710 Regulation Name: Esophagoscope (Flexible or Rigid) and Accessories Regulatory Class: II Product Code: EOX, FDX, BTR Dated: May 15, 2019 Received: May 16, 2019
Dear Eric Bannon:
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/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.
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.
1
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-regulatoryinformation/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 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 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 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,
Shanil P. Haugen, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182159
Device Name Strome-Blitzer Cytology Balloon
Indications for Use (Describe)
The Strome-Blitzer Cytology Balloon device is indicated for use in the 4-quadrant collection and retrieval of surface cells from the esophagus in adults (22 years of age or older). The device may be delivered transorally under direct endoscopic visualization.
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
5.0 510(K) SUMMARY FOR STROME-BLITZER CYTOLOGY BALLOON CATHETER DEVICE
| Date of Preparation: | August 6, 2018 |
|---|---|
| Applicant (Submitter): | ADN International LLC |
| 425 West 59th Street | |
| New York, NY 10019 | |
| Tel: (917) 703-2517 | |
| Correspondent Contact Information: | Eric Bannon |
| AlvaMed Inc. | |
| 1116 Great Plain Avenue, #1 | |
| Needham, MA 02492 | |
| Tel: (888) 331-3485 | |
| Fax: (617) 249-0955 | |
| e-mail: | |
| ebannon@alvamed.com | |
| Device Proprietary Name: | Strome-Blitzer Cytology |
| Balloon | |
| Device Common Name: | Cytology Balloon |
| Device Classification Regulation & | |
| Name: | 21 CFR 874.4710, |
| Esophagoscope (flexible or | |
| rigid) and accessories | |
| Device Classification & Product Code: | Class II, EOX, FDX, BTR |
| Prior FDA Document Numbers: | None |
| Basis of Submission: | Traditional 510(k) based on |
| K911588 (predicate device), | |
| K103437 (reference device) | |
| Number of Devices in Submission: | 1 |
4
5.1 Indications for Use
The Strome-Blitzer Cytology Balloon device is indicated for use in the 4-quadrant collection and retrieval of surface cells from the esophagus in adults (22 years of age or older). The device may be delivered transorally under direct endoscopic visualization.
5.2 Device Description
The Strome-Blitzer Cytology Balloon is an inflatable biopsy platform. It consists of a catheter with a silicone balloon at its distal end. The balloon has 6 collection pleats on its surface. Inside each pleat are 2 cytology collection strips for specimen collection. While the balloon is uninflated, the strips are covered by the balloon pleats. When inflated, the strips are exposed. The balloon inflates and deflates with the use of a syringe and attached catheter, and is a sterile, single-use device. There are 4 location indicator dots on the proximal balloon surface for orientation during esophagoscopy.
| Subject:
Strome-Blitzer
Cytology Balloon | Predicate Device:
Brandt Esophageal
Cytology Balloon | Reference Device:
US Endoscopy
Cytology Brush | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | ADN International LLC | Wilson-Cook Medical,
Inc. | United States
Endoscopy Group, Inc. |
| 510(k) Number | (to be determined) | K911588 | K103437 |
| Product Code | EOX, FDX, BTR | EOX | FDX |
| Regulation
Number | 874.4710 | 874.4710 | 876.1500 |
| Regulation
Description | Esophagoscope
(flexible or rigid) and
accessories | Esophagoscope (flexible
or rigid) and accessories | Endoscope and
accessories |
| Common
Name | Cytology balloon | Cytology balloon | Endoscopic cytology
brush |
| | Subject:
Strome-Blitzer
Cytology Balloon | Predicate Device:
Brandt Esophageal
Cytology Balloon | Reference Device:
US Endoscopy
Cytology Brush |
| Indications for
Use | The Strome-Blitzer
Cytology Balloon
device is indicated for
use in the 4-quadrant
collection and
retrieval of surface
cells from the
esophagus in adults
(22 years of age or
older). The device
may be delivered
transorally under
direct endoscopic
visualization. | The Brandt
Esophageal Cytology
Balloon is indicated for
use in the collection
and retrieval of surface
cells in the esophagus. | The disposable
Cytology Brush is
intended to be used
to retrieve cytological
cell samples in the
gastrointestinal tract. |
| Sterility | EO Sterilization | Data Not Available | EO sterilization |
| Single-Use | Yes | Yes | Yes |
| Biocompat-
ibility | Complies with ISO
10993-1 | Since 510(k) cleared, it
is assumed that the
device is biocompatible | Since 510(k) cleared, it
is assumed that the
device is biocompatible |
| Design
Characteristics | Balloon with pleats
that open upon
inflation to expose
cytology collection
strips Device can be
delivered
transorally (under
direct
esophagoscopic
visualization) | Balloon with nipple-
like projections for
cytology collection Passed alongside
scope: transoral
delivery (under
direct
esophagoscopic
visualization) Cytology results
were similar
between balloon
and cytology brush | Brush with
abrasive bristles
for cytology
collection Passes through
scope working
channel to desired
location and is
rotated to collect
cells |
| | Subject:
Strome-Blitzer
Cytology Balloon | Predicate Device:
Brandt Esophageal
Cytology Balloon | Reference Device:
US Endoscopy
Cytology Brush |
| Dimensions | Uninflated balloon outer diameter: 7 mm (without application of negative pressure) Inflated balloon minimum outer diameter: 20 mm Balloon length (without catheter): 84 mm Minimum total working length: 1250 mm | Uninflated balloon diameter: 10 mm Inflated balloon outer diameter: 35 mm Balloon length: 25 mm | Brush diameter: 1-3 mm (various adult sizes) Brush length: 1200-2400 mm (various adult sizes) |
5.3 Substantial Equivalence Information
5
6
5.4 Comparison to Predicate Device
Both devices are designed for collection of esophageal tissue for cytology analysis. Both devices share similar designs, modes of operation, single-use disposition and sterility, intended use, and materials.
The primary differences between the predicate and subject devices are in their methods of sample collection and routes of delivery. The Strome-Blitzer Cytology Balloon uses cvtology collection strips in pleats on the balloon surface rather than the nipple-like projections used in the predicate Brandt Balloon. The U.S. Endoscopy Cytology Brush (K103437) device was used in testing of the subject device in animals due to the unavailability of the Brandt Balloon and for its similarity to the cytology collection strips used in the subject device.
Finally, as demonstrated in the results of design verification, bench testing, and animal studies, any differences in design do not adversely affect performance compared to the predicate device, and the devices are substantially equivalent.
5.5 Summary of Supporting Data
ADN International LLC conducted the following performance testing for the Strome-Blitzer Cytology Balloon device.
5.5.1 Dimensional and Functional Performance Testing (Bench)
- . Cytology collection strip inspection
- Balloon bond joint inspection
- Distal atraumatic tip inspection ●
7
K182159 Page 5 of 5 5.0 510(k) Summary Strome-Blitzer Cytology Balloon Traditional 510(k)
- . Device trackability and balloon to shaft joint integrity test
- . Device total length
- Balloon length
- . Catheter shaft internal diameter
- . Catheter shaft outer diameter
- Maximum balloon profile (deflated)
- . Axial orientation indicator dot inspection
- . Balloon inflation-deflation cycle test
- . Device kink resistance to evaluate balloon's ability to contain strips during device insertion and removal
- Balloon pressure evaluation and burst test
- . Shaft to Luer joint tensile strength
- . Shaft to balloon ioint tensile strenath
5.5.2 Animal Study of Safety and Effectiveness
The subject device was compared to the U.S. Endoscopy Cytology Brush due to commercial unavailability of the Brandt Balloon and similarity of cytology collection strips on the subject device to the action of the Cytology Brush.
Six swine underwent transoral esophagoscopy and cytology collection with the Strome-Blitzer Cytology Balloon and the U.S. Endoscopy Cytology Brush. There were no procedure-related complications in this study. Acceptance criteria for the subject device were met: cytologic examination of esophageal smears prepared with the Strome-Blitzer Cytology Balloon resulted in diagnostically useful cytology samples of high cellularity that were morphologically comparable to those generated with the reference cytology brush. Cytology collection procedures were well tolerated by the animals, with no inflammatory response or edema in the tissue of the distal esophagus in control or test areas.
5.6 Conclusion
A comparison of the Strome-Blitzer Cytology Balloon to the legally marketed predicate demonstrates the same intended use. Bench and animal testing support the conclusion that any differences in product design between subject and predicate do not raise new questions of safety and effectiveness for the proposed indication. Comparative testing demonstrates the subject device meets or exceeds established specifications. The device performs as well as or better than the legally marketed predicate, supporting substantial equivalence.