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.

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.

AI/ML Overview

The provided text describes a medical device, the "Strome-Blitzer Cytology Balloon," and its 510(k) premarket notification to the FDA. The information focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria in the context of an AI/ML algorithm. Therefore, many of the requested details, such as the effect size of human reader improvement with AI assistance, sample sizes for training sets of AI, or ground truth for AI model development, are not present in this document.

However, I can extract the acceptance criteria and study details related to the device's performance as described in the provided text.

Acceptance Criteria and Reported Device Performance (Device-Specific, not AI/ML):

Acceptance Criteria (Strome-Blitzer Cytology Balloon)	Reported Device Performance
Cytologic examination of esophageal smears prepared with the device results in diagnostically useful cytology samples.	Met: Resulted in diagnostically useful cytology samples.
Cytology samples demonstrate high cellularity.	Met: Samples showed high cellularity.
Cytology samples are morphologically comparable to those generated with the reference cytology brush (U.S. Endoscopy Cytology Brush).	Met: Samples were morphologically comparable to the reference cytology brush.
Cytology collection procedures are well tolerated by the animals (no adverse events or significant tissue response).	Met: 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.

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 6 swine.
- Data Provenance: Not explicitly stated (e.g., country of origin), but the study was an "Animal Study," implying prospective data collection specifically for this evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that "cytologic examination" was performed to evaluate the samples. However, it does not state the number of experts used, nor their specific qualifications, for establishing the ground truth of "diagnostically useful cytology samples of high cellularity" or "morphologically comparable."
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method for the evaluation of cytology samples from the animal study.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was a study comparing a new medical device (a cytology balloon) to a reference device (a cytology brush) in an animal model, not an AI/ML algorithm requiring human reader performance improvement metrics.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth appear to be based on cytologic examination of the collected samples, which implies expert evaluation (likely by pathologists or cytotechnologists). The document states "cytologic examination... resulted in diagnostically useful cytology samples of high cellularity that were morphologically comparable..." This suggests an expert assessment of the cellular quality and morphology.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. As above, this is a physical device, not an AI/ML algorithm.

Summary

{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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

5.0 510(K) SUMMARY FOR STROME-BLITZER CYTOLOGY BALLOON CATHETER DEVICE

Date of Preparation:	August 6, 2018
Applicant (Submitter):	ADN International LLC425 West 59th StreetNew York, NY 10019Tel: (917) 703-2517
Correspondent Contact Information:	Eric BannonAlvaMed Inc.1116 Great Plain Avenue, #1Needham, MA 02492Tel: (888) 331-3485Fax: (617) 249-0955e-mail:ebannon@alvamed.com
Device Proprietary Name:	Strome-Blitzer CytologyBalloon
Device Common Name:	Cytology Balloon
Device Classification Regulation &Name:	21 CFR 874.4710,Esophagoscope (flexible orrigid) and accessories
Device Classification & Product Code:	Class II, EOX, FDX, BTR
Prior FDA Document Numbers:	None
Basis of Submission:	Traditional 510(k) based onK911588 (predicate device),K103437 (reference device)
Number of Devices in Submission:	1

{4}------------------------------------------------

5.1 Indications for Use

5.2 Device Description

Subject:Strome-BlitzerCytology Balloon	Predicate Device:Brandt EsophagealCytology Balloon	Reference Device:US EndoscopyCytology Brush
Manufacturer	ADN International LLC	Wilson-Cook Medical,Inc.	United StatesEndoscopy Group, Inc.
510(k) Number	(to be determined)	K911588	K103437
Product Code	EOX, FDX, BTR	EOX	FDX
RegulationNumber	874.4710	874.4710	876.1500
RegulationDescription	Esophagoscope(flexible or rigid) andaccessories	Esophagoscope (flexibleor rigid) and accessories	Endoscope andaccessories
CommonName	Cytology balloon	Cytology balloon	Endoscopic cytologybrush
	Subject:Strome-BlitzerCytology Balloon	Predicate Device:Brandt EsophagealCytology Balloon	Reference Device:US EndoscopyCytology Brush
Indications forUse	The Strome-BlitzerCytology Balloondevice is indicated foruse in the 4-quadrantcollection andretrieval of surfacecells from theesophagus in adults(22 years of age orolder). The devicemay be deliveredtransorally underdirect endoscopicvisualization.	The BrandtEsophageal CytologyBalloon is indicated foruse in the collectionand retrieval of surfacecells in the esophagus.	The disposableCytology Brush isintended to be usedto retrieve cytologicalcell samples in thegastrointestinal tract.
Sterility	EO Sterilization	Data Not Available	EO sterilization
Single-Use	Yes	Yes	Yes
Biocompat-ibility	Complies with ISO10993-1	Since 510(k) cleared, itis assumed that thedevice is biocompatible	Since 510(k) cleared, itis assumed that thedevice is biocompatible
DesignCharacteristics	Balloon with pleatsthat open uponinflation to exposecytology collectionstrips Device can bedeliveredtransorally (underdirectesophagoscopicvisualization)	Balloon with nipple-like projections forcytology collection Passed alongsidescope: transoraldelivery (underdirectesophagoscopicvisualization) Cytology resultswere similarbetween balloonand cytology brush	Brush withabrasive bristlesfor cytologycollection Passes throughscope workingchannel to desiredlocation and isrotated to collectcells
	Subject:Strome-BlitzerCytology Balloon	Predicate Device:Brandt EsophagealCytology Balloon	Reference Device:US EndoscopyCytology 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.

Regulation Number and Section

§ 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.