Predicate Devices

K053267, K022578, K991794, K983144, K052241, K043602, K002931, K041123, K040919, K032473, K002008, K992898

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical surgical tools and their use with fluoroscopic imaging guidance. There is no mention of AI, ML, or any software-driven analysis or processing of data.

Therapeutic

Yes
The device is described as a set of specialized surgical instruments used to perform a specific medical procedure (percutaneous lumbar decompressive procedures) for the treatment of various spinal conditions, indicating a therapeutic purpose.

Diagnostic

No

The device is a set of surgical instruments used for interventional procedures (retracting, grasping, and excising tissue), not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components made of stainless steel and plastic, such as retractors, trocars, portals, and a surgical clamp. These are hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the X-Sten MILD Tool Kit is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to perform percutaneous lumbar decompressive procedures for treating spinal conditions. This is a surgical procedure performed on the patient's body, not a test performed on samples taken from the body.
Device Description: The description details surgical instruments for retracting, grasping, and excising tissue in the lumbar spine. These are tools for physical manipulation and removal of tissue during surgery.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device is used for treatment, not diagnosis.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The X-Sten MILD Tool Kit does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The X-Sten MILD Tool Kit is a set of specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.

Product codes

HRX

Device Description

The X-Sten MILD Tool Kit is a set of specialized surgical tools for retracting, grasping and excising tissue in the lumbar spine. The kit consists of the following components:

MILD Tissue Retractor Cobra Device 8.5 Gauge, 8.5" working length .
MILD Trocars and Handles- 7 Gauge, 6.5" working length ●
MILD Portals 6 Gauge, 6.5" working length ●
Surgical Clamp 14" length .

The Trocars, Portals (cannula) and Retractor devices contain stainless steel shafts and plastic handle components. The radiopaque tip and pistol-grip handle aid the user in the Minimally Invasive Lumbar Decompression (MILD) Retractor device positioning and Under fluoroscopic imaging guidance, the MILD Retractor device is advancement. inserted through the Portal into the posterior lumbar spine to retract and grasp tissue. An accessory Clamp can be used to position the Portal and allow handling outside of the fluoroscopic imaging field. A cutting mechanism on the MILD Retractor is advanced by depressing a handle trigger. Excised tissue is removed using an integrated member.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Under fluoroscopic imaging guidance (using fluoroscope or endoscope/fluoroscope)

Anatomical Site

Lumbar spine / posterior lumbar spine

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)

Performance Testing: The X-Sten Mild Tool Kit Retractor and Access instruments passed the designated mechanical test criteria established for the product assemblies. The tests verified the devices have the adequate strength and integrity to safely and effectively perform the stated intended use. Cadaver evaluations demonstrate that tissue can be simultaneously retracted, grasped and excised from the posterior lumbar spine using image guided techniques.
Biocompatibility: The patient contacting stainless steel materials used in the X-Sten MILD Tool Kit were tested for "Externally Communicating Devices, Tissue/Dentin/Bone, Limited Contact", less than 24 hours, as described in ISO 10993 and the FDA Blue Book Memorandum #G95-1. The biocompatibility is substantially equivalent to the predicate devices. The documentation substantiates that the X-Sten MILD Tool Kit Retractor and Access Instruments' patient contacting components fulfill the acceptance criteria for biocompatibility. These results are equivalent to those claimed of the predicates and there were no new types of safety or effectiveness questions.
Sterilization: The MILD Tool Kit is labeled sterile, for single-use only. The packaging and contents will be sterilized with gamma irradiation by a validated process to a Sterility Assurance Level (SAL) of 10th per AAMI / ISO 11137 and AAMI TIR 27.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K053267, K022578, K991794, K983144, K052241, K043602, K002931, K041123, K040919, K032473, K002008, K992898

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

Summary

0

MILD Tool Kit - Premarket Notification [510(k)] Submission

X-Sten Corp Page 1 of 3, Tab 5

ko6 2038 Tab 5

Premarket Notification [510(k)] Summary

Trade Name:	X-Sten MILD Tool Kit
Common Name:	Arthroscope and Accessories	DEC 19 2006
Classification /Name:	Class II; 21 CFR, part 888.1100
Arthroscope
Device Code:	HRX
Manufacturer's Name:	X-Sten Corp
Address:	2362 Qume Drive, Suite D
San Jose, CA 95131-1841
Corresponding Official:	Timothy M. Reeves
Title:	Director, Regulatory, Quality and Clinical Affairs
Address:	2362 Qume Drive, Suite D
San Jose, CA 95131-1841
Telephone:	408-437-3101
Predicate Devices:	K053267
K022578
K991794
K983144
K052241
K043602
K002931
K041123
K040919
K032473
K002008
K992898	Endius Atavi System
Endius FlexTip Blade
Endius Endoscopic Spinal Access System
Endius Flexposure Retractor
Ellman International Disc-Fx System
Medtronic MAST QUADRANT Retractor
Medtronic METRx
HydroCision AthroJet Resector XT
Clarus 21200 Nucleotome Probe Set
Stryker Dekompressor Percutaneous
Discectomy Probe
Surgical Dynamics Spinal Retractor
Bright Medical Dilatation Retractor System
Intended Use:	The X-Sten MILD Tool Kit is a set of specialized surgical
instruments intended to be used to perform percutaneous
lumbar decompressive procedures for the treatment of
various spinal conditions

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product addressed in this submission may be lawfully market approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent or patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.

1

Device Description:

The X-Sten MILD Tool Kit is a set of specialized surgical tools for retracting, grasping and excising tissue in the lumbar spine. The kit consists of the following components:

MILD Tissue Retractor Cobra Device 8.5 Gauge, 8.5" working length .
MILD Trocars and Handles- 7 Gauge, 6.5" working length ●
MILD Portals 6 Gauge, 6.5" working length ●
Surgical Clamp 14" length .

The Trocars, Portals (cannula) and Retractor devices contain stainless steel shafts and plastic handle components. The radiopaque tip and pistol-grip handle aid the user in the Minimally Invasive Lumbar Decompression (MILD) Retractor device positioning and Under fluoroscopic imaging guidance, the MILD Retractor device is advancement. inserted through the Portal into the posterior lumbar spine to retract and grasp tissue. An accessory Clamp can be used to position the Portal and allow handling outside of the fluoroscopic imaging field. A cutting mechanism on the MILD Retractor is advanced by depressing a handle trigger. Excised tissue is removed using an integrated member.

| Attributes | X-Sten | Clarus
Med | Stryker | Hydro-
Cision | Ellman
Int'l | Bright
Med | Surgical
Dynamic | Medtronic | Endius | |
|----------------------|-----------------------------------------------------------------------------------------------------------|-------------------|-------------------------------------------------------------------------------------|------------------|---------------------|---------------|----------------------------------------------------------------|------------------------|------------------------------|--|
| Intended
Use | Minimally invasive image-guided tissue resection during decompressive surgery within the
lumbar spine. | | | | | | | | | |
| Target
Population | Products are used for various procedures in patients indicated for spinal decompressive surgery. | | | | | | | | | |
| Device
Class | | | Arthroscope | | | Retractor | | Arthroscope; Retractor | | |
| Approach | | | Percutaneous | | | | Minimally Invasive Portal | | | |
| Target
Anatomy | | Spine /
Lumbar | | Spine / Disc | | | | Spine / Lumbar | | |
| Imaging | | | Fluoroscope | | | Endoscope | | | Endoscope /
Fluoroscope | |
| Materials | | | Stainless Steel Shafts and Plastic Handles (metal
discectomy probes for Stryker) | | | | Stainless Steel Cannula, Dilatators and/or
Tissue Resectors | | | |
| Action | Retract
Grasp
Cut | | Cut /
Aspirate | | Ablate
Coagulate | | Access
Retract | | Retract
Grasp
Cut | |
| Labeling | | | Sterile Kit, Single-use | | | | Non-sterile, Re-use | | Sterile
& Non-
sterile | |

Comparison Table of the X-Sten MILD Tool Kit to the Predicates

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product addressed in this submission may be lawfully marketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a pagentability perspective, from any of the other devices referenced in this filing

2

X-Sten Corp Page 3 of 3, Tab 5

Performance Testing

The X-Sten Mild Tool Kit Retractor and Access instruments passed the designated mechanical test criteria established for the product assemblies. The tests verified the devices have the adequate strength and integrity to safely and effectively perform the stated intended use. Cadaver evaluations demonstrate that tissue can be simultaneously retracted, grasped and excised from the posterior lumbar spine using image guided techniques.

Biocompatibility

The patient contacting stainless steel materials used in the X-Sten MILD Tool Kit were tested for "Externally Communicating Devices, Tissue/Dentin/Bone, Limited Contact", less than 24 hours, as described in ISO 10993 and the FDA Blue Book Memorandum #G95-1. The biocompatibility is substantially equivalent to the predicate devices. The documentation substantiates that the X-Sten MILD Tool Kit Retractor and Access Instruments' patient contacting components fulfill the acceptance criteria for biocompatibility. These results are equivalent to those claimed of the predicates and there were no new types of safety or effectiveness questions.

Sterilization

The MILD Tool Kit is labeled sterile, for single-use only. The packaging and contents will be sterilized with gamma irradiation by a validated process to a Sterility Assurance Level (SAL) of 10th per AAMI / ISO 11137 and AAMI TIR 27.

Substantial Equivalence

The X-Sten MILD Tool Kit is substantially equivalent in function, technology and intended use to commercially available predicate devices for image guided lumbar spinal decompression procedures. Applicable predicates are identified in the provided comparison table. These include devices for minimally invasive surgery and percutaneous discectomy.

The X-Sten MILD Tool Kit was tested in accordance with 21 CFR 807.87(d - g) to verify substantial equivalence to the predicate devices. The technological comparisons to the predicates support the substantial equivalence of the MILD Tool Kit for its intended use. Combined with the product performance test results and the substantial equivalence discussions, the X-Sten MILD Tool Kit is demonstrated to be substantially equivalent to the predicates. The MILD Tool Kit has the same intended use and similar technological characteristics as the predicate devices. Any differences between the MILD devices and the predicates do not raise any new types of safety or effectiveness questions.

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product addressed in this submission may be lawfully market approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

X-Sten Corporation % Mr. Timothy M. Reeves Director of Regulatory, Quality and Clinical Affairs 2362 Qume Drive, Suite D San Jose, California 95131-1841

DEC 1 9 2006

Re: K062038

Trade/Device Name: X-Sten MILD Tool Kit Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: November 27, 2006 Received: November 28, 2006

Dear Mr. Reeves:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

4

Page 2 - Mr. Timothy M. Reeves

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Mark N. Mellon

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(k) Number (if known): _ KO62038

Device Name: X-Sten MILD Tool Kit

Indications for Use:

The X-Sten MILD Tool Kit is a set of specialized surgical instruments intended to be File A bled MILL - Fourneous lumbar decompressive procedures for the treatment of various spinal conditions.

x_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	14062038

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