Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
Device Facts
| Record ID | K262420 |
|---|---|
| Device Name | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) |
| Applicant | Serpex Medical |
| Product Code | GEH · General, Plastic Surgery |
| Decision Date | Sep 2, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4350 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Maverix CryoBiopsy Pro (MCB) Probe is intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryo-adhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.
Device Story
MCB Pro is a sterile, single-use flexible cryoprobe for interventional endoscopy. It uses a disposable N2O cartridge (Cryo Cartridge) to achieve cooling via the Joule-Thomson effect. The probe features an adjustable outer sheath and depth stop for controlled tip extension. During procedures, the clinician inserts the probe through an endoscope/bronchoscope; the distal tip is exposed at the target site. Activation via an inline handle triggers rapid cooling, causing tissue to freeze and adhere to the tip (cryoadhesion). The clinician then withdraws the probe to retrieve the sample or devitalize tissue. Used in clinical settings by physicians; provides real-time tissue sampling and recanalization capabilities. Benefits include precise, minimally invasive tissue collection and palliative obstruction removal.
Clinical Evidence
No human clinical data provided. Evidence consists of bench testing (mechanical integrity, freezing performance, sheath/depth stop function, sterile barrier, shelf life) and GLP-compliant animal testing (in vivo porcine model) to evaluate biopsy performance and safety. Biocompatibility testing (ISO 10993-1) confirmed safety for limited-duration tissue contact.
Technological Characteristics
Materials: Stainless steel, plastics. Principle: Joule-Thomson effect (N2O expansion). Form factor: Flexible probe with inline handle and adjustable outer sheath. Connectivity: Standalone (no electronic/networked components). Sterilization: E-beam radiation (ISO 11137). Standards: ISO 10993-1, ISO 11137, ISO 11607, ASTM F1980, ASTM F640, IEC 62366-1.
Indications for Use
Indicated for palliative tissue devitalization and biopsy collection in patients undergoing interventional endoscopic procedures (e.g., bronchoscopy) for removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, or tumors.
Regulatory Classification
Identification
(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.
Predicate Devices
- ERBECRYO 2 Cryosurgical Unit and Accessories, Erbe Flexible Cryoprobes (K190651)
Submission Summary (Full Text)
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
September 2, 2026
Serpex Medical
Krystal Santiago
Regulatory Affairs
3350 Scott Blvd.
Suite 37b
Santa Clara, California 95054
Re: K262420
Trade/Device Name: Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000);
Maverix Cryo Cartridge (CC-1000)
Regulation Number: 21 CFR 878.4350
Regulation Name: Cryosurgical unit and accessories
Regulatory Class: Class II
Product Code: GEH
Dated: July 15, 2026
Received: July 16, 2026
Dear Krystal Santiago:
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.
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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-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).
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K262420 - Krystal Santiago
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Sincerely,
Colin K.
Chen -S
Digitally signed by
Colin K. Chen -S
Date: 2026.09.02
08:15:20 -04'00'
Colin Kejing Chen, Ph.D.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K262420
Device Name
Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000);
Maverix Cryo Cartridge (CC-1000)
Indications for Use (Describe)
The Maverix CryoBiopsy Pro (MCB) Probe is intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryo-adhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies.
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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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740 EF
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K262420
# 510(k) SUMMARY
[AS REQUIRED BY 21 CFR 807.92]
| Field | Value |
| --- | --- |
| Submitted By | Serpex Medical, 3350 Scott Blvd. Suite 37B, Santa Clara, CA 95054 |
| Contact Person | Krystal Santiago, Regulatory Affairs |
| Date Prepared | July 15, 2026 |
| Trade/Proprietary Name | Maverix Cryo Biopsy Pro (MCB Pro) Probe (MCBP-1000); Cryo Cartridge (CC-1000) |
| Common Name | Cryosurgical Unit and Accessories |
| Classification Name and Code | Cryosurgical Unit and Accessories (21 CFR 878.4350) |
| Regulatory Class | II |
| Product Code | GEH |
| Legally Marketed Predicate Device | ERBECRYO 2 Cryosurgical Unit and Accessories, Erbe Flexible Cryoprobes (K190651), cleared January 7, 2020 |
## Device Description:
The Maverix Cryo Biopsy Pro (MCB Pro) Probe (Model MCBP-1000) is a sterile, single-use flexible cryoprobe used for tissue devitalization and tissue or foreign body collection during interventional endoscopic procedures using commercial access instruments, including bronchoscopes and endoscopes.
The MCB Pro system consists of two components supplied in separate packaging: (1) the sterile MCB Pro Probe, comprising a flexible probe with an inline handle, an adjustable outer sheath, and a distal working end; and (2) the Cryo Cartridge (Model CC-1000), a non-sterile, single-use disposable nitrous oxide (N2O) refrigerant cartridge housed within a protective cartridge nest. The Cryo Cartridge is inserted into the cartridge housing at the proximal end of the device by a non-sterile surgical assistant and is suspended from an IV pole or equivalent equipment outside the sterile field during use, while the distal working end of the MCB Pro Probe remains within the sterile field.
The MCB Pro Probe operates via the Joule-Thomson effect: pressurized N2O is delivered to the probe tip through a fine orifice, producing rapid cooling via gas expansion. Upon activation, the cooled probe tip causes tissue to freeze and adhere by cryoadhesion, and tissue samples are retrieved by withdrawing the probe while freezing remains engaged. The pointed distal tip is covered by the outer sheath during placement through the access instrument and is exposed at the target tissue location. The outer sheath provides a user-set working length, set once per procedure to accommodate the bronchoscope working channel in use, and the inline handle incorporates a depth stop that sets the maximum tip extension during sampling. A maximum of two Cryo Cartridges may be used with a single MCB Pro Probe when the procedure requires additional freeze time.
Serpex Medical
Traditional 510(k)
MCB Pro
Page 1 of 5
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K262420
# Intended Use / Indications for Use:
The Maverix Cryo Biopsy Pro (MCB Pro) Probe is intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization), and tissue biopsies.
# Similarities and Differences of the Subject Device to the Predicate Device (Predicate Comparison / Substantial Equivalence):
| Characteristics | K190651 ERBECRYO 2 Cryosurgical Unit and Accessories (Erbe Flexible Cryoprobes) | MCB Pro (MCBP-1000) and Cryo Cartridge (CC-1000) (Serpex Medical) |
| --- | --- | --- |
| Manufacturer | Erbe Elektromedizin GmbH (Germany) | Serpex Medical |
| Device Name | ERBECRYO 2 Cryosurgical Unit and Accessories, Erbe Flexible Cryoprobes | Maverix Cryo Biopsy Pro (MCB Pro) Probe |
| Indications for Use (Flexible Cryoprobes) | The Erbe Flexible Cryoprobes are intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies. | The Maverix Cryo Biopsy Pro (MCB Pro) Probe is intended for palliative devitalization (destruction) of tissue during interventional procedures by the application of extreme cold and cryoadhesion for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies. |
| Prescription or OTC | Prescription | Same |
| Principle of Operation | Joule-Thomson effect: expansion of compressed gas produces rapid cooling at probe tip; cryoadhesion of tissue to tip for retrieval or devitalization | Same |
| Refrigerant Gas | Carbon Dioxide (CO2) | Nitrous Oxide (N2O) |
| Gas Delivery System | Console with external CO2 cylinder; footswitch activation | Self-contained disposable N2O cartridge; inline handle activation |
| Probe Type | Flexible cryoprobe | Same |
| Working Length | Fixed working length per probe model (900mm or 1150mm) | Sheath-adjustable working length, set once per procedure to accommodate the endoscope or bronchoscope working channel |
| Tip Configuration | Fixed tip length per probe model; no depth stop | User-set tip extension via a depth stop on the inline handle; adjustable outer sheath with locking function |
| Tip Geometry | Blunt tip; exposed during placement through endoscope 1.1 or 2.4mm OD | Pointed tip; sheathed during placement; exposed at target tissue location. Min OD 0.8mm Max OD 1.2mm |
| Activation Method | Footswitch connected to console | Inline handle on probe assembly |
Serpex Medical
Traditional 510(k)
MCB Pro
Page 2 of 5
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| Patient Contact Materials (Flexible Cryoprobes) | Stainless steel, silicone, plastics | Stainless steel, plastics |
| --- | --- | --- |
| Contact Duration | Limited duration (<24 hours) | Same |
| Provided Condition (Flexible Cryoprobes) | Sterile, single-use | Same |
| Sterilization Method | Ethylene Oxide (EtO) per ISO 11135 | Electron Beam (E-beam) Radiation per ISO 11137-1/-2 |
| Gas Canister | Non-Sterile | Same |
| Shelf Life | Three (3) years | Six (6) months (MCB Pro), One (1) year Cryo Cartridge |
| Endoscope Compatibility | Compatible with bronchoscopes and endoscopes | Compatible with bronchoscopes and endoscopes |
The technological differences between the MCB Pro Probe and the predicate device do not raise new questions of safety or effectiveness. Performance testing confirms that the MCB Pro Probe is as safe and effective as the predicate device for its intended use.
### Summary of Biocompatibility Testing:
Biocompatibility testing was conducted in accordance with ISO 10993-1:2018 and the FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing within a Risk Management Process" (September 2023). Testing was performed under Good Laboratory Practice (GLP) conditions at an ISO 17025-accredited laboratory on final finished, sterilized patient-contacting portions of the device.
The MCB Pro Probe is classified as a limited-duration (<24 hours) tissue-contacting device. Five biocompatibility endpoints were evaluated: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity. All five endpoints passed. The device materials demonstrated biocompatibility for the intended contact type and duration.
### Summary of Sterilization Validation:
The MCB Pro Probe is provided sterile to the customer and is a single-use device. Sterilization by electron beam (e-beam) radiation was validated in accordance with ISO 11137-1 and ISO 11137-2. A sterility assurance level (SAL) of 10⁻⁶ was achieved. The Cryo Cartridge is a non-sterile, single-use, non-patient-contacting component and does not require sterilization.
### Summary of Shelf-Life Validation:
The shelf life of the packaged MCB Pro Probe was validated on sterilized samples following accelerated aging per ASTM F1980 and transport simulation per ASTM D4169 / ISTA 3A. Sterile
Serpex Medical
Traditional 510(k)
MCB Pro
Page 3 of 5
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barrier integrity was evaluated in accordance with ISO 11607-1 and ISO 11607-2, including seal strength testing per ASTM F88 and bubble leak testing per ASTM F2096. Samples passed all evaluations at the validated 6-month shelf life.
# Summary of Performance Testing:
Design verification and validation testing was performed to evaluate the physical, performance, and safety specifications of the subject device in accordance with applicable standards, guidance documents, and internal design control procedures per 21 CFR 820.30.
Comparative testing was conducted to determine freezing performance. Comparative ex vivo tissue testing on three different tissues (bovine liver, porcine kidney, and porcine lung) and GLP animal testing in an in vivo porcine model were conducted to compare biopsy performance and in vivo safety, respectively. Mechanical integrity, sheath mechanism and working-length function, tip-extension control, cartridge and gas delivery performance, sterile barrier and shelf life, and human factors validation were also conducted. Together with standards testing, biocompatibility testing, and sterilization validation, these data demonstrate that the technological characteristics of the proposed device do not raise any new questions of safety or effectiveness.
# Standards Applied:
- ISO 15223-1, Fourth edition 2021-07: Medical devices, Symbols to be used with information to be supplied by the manufacturer
- ISO 20417, First edition 2021-04: Medical devices, Information to be supplied by the manufacturer
- ISO 14971, Third edition 2019-12: Medical devices, Application of risk management to medical devices
- ISO 10993-1, Fifth edition 2018-08: Biological evaluation of medical devices, Evaluation and testing within a risk management process
- ISO 11137-1, Second edition 2025-04: Sterilization of health care products, Radiation, Part 1: Requirements for development, validation and routine control
- ISO 11137-2, Third edition 2013-06 [AMD1:2022]: Sterilization of health care products, Radiation, Part 2: Establishing the sterilization dose
- ISO 11137-3, Second edition 2017-06: Sterilization of health care products, Radiation, Part 3: Guidance on dosimetric aspects
- ASTM F1980-21: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F640-23: Standard Test Methods for Determining Radiopacity for Medical Use
- IEC 62366-1, Edition 1.1 2020-06: Medical devices, Application of usability engineering to medical devices
- ISO 11607-1, Second edition 2019-02 [AMD1:2023]: Packaging for terminally sterilized medical devices, Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2, Second edition 2019-02 [Including AMD1:2023]: Packaging for terminally sterilized medical devices, Part 2: Validation requirements for forming, sealing and assembly processes
Serpex Medical
Traditional 510(k)
MCB Pro
Page 4 of 5
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K262420
- ASTM F1886/F1886M-16: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ASTM F88/F88M-23: Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F2096-11 (Reapproved 2019): Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ASTM D4169-23e1: Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM D4332-22: Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ISTA 3A 2018: Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
# Conclusion:
The Maverix Cryo Biopsy Pro (MCB Pro) Probe has the same intended use as the predicate device (K190651). Differences have been identified between the subject device and predicate. However, testing and analysis demonstrate that none of these differences raises different questions of safety and effectiveness compared to the predicate device. The performance testing demonstrates the subject device is as safe and effective as the predicate device.
Serpex Medical
Traditional 510(k)
MCB Pro
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